Orca1

Data catalog

510(k) premarket notifications

About 178K records

More records

Continuing the 510(k) premarket notifications list, 1000 records per page.

  1. K955908BOEHRINGER MANNHEIM IGM ASSAY
  2. K810399APC IMPLANTABEL PACING LEAD, MODEL 3264
  3. K820895CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI
  4. K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…
  5. K123915DE48-PLUS
  6. K890927KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.0
  7. K801753ADT BONE MARROW BIOPSY-ASPIR. NEELDE
  8. K930338ORTHOCEPH OC100
  9. K992512ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION…
  10. K940299ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTRODE WITH…
  11. K864334ACUSYST-P (CELL CULTURE EQUIPMENT)
  12. K893829POWERED EYE WASH
  13. K770545DURA-VAC
  14. K033401MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
  15. K922382INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE
  16. K863598VIDEO CAMERA SYSTEM
  17. K250381Deepsight NeedleVue LC1 Ultrasound System
  18. K222225Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
  19. K893378PROTHROMBIN TIME (PT) BY HEMOCHRON
  20. K232285U-Lite PRO
  21. K100837PACENTRIC CONNECT, TRAVELER AND WEB
  22. K142500One Way Soft Valve
  23. K823501ZEE SPHYGMOMANOMETER
  24. K972372GERM TRAPPER SUCTION TUBE HOLDER
  25. K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
  26. K955192SAS SALMONELLA H T ANTISERUM
  27. K953364SPECULITE
  28. K833290C & B 40 PENTRO C & B40
  29. K083229E.S TECK ( ELECTRO SENSOR TECK)
  30. K904050MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA
  31. K940091INNOVA VAGINAL EMG SENSING ELECTRODE
  32. K870309WHITE PLUME ABSORBENT COTTON WOOL
  33. K213493Fortilink with TiPlus Technology
  34. K93133816 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)
  35. K893977GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
  36. K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
  37. K863682PATHFINDER(TM) SPECIMEN COLLECTION KIT
  38. BK090018Test, Qualitative, for HLA, Non-Diagnostic
  39. K220378Sparta 3-Ply Surgical Disposable Face Mask
  40. K071194RAPHAEL COLOR ASV VENTILATOR
  41. K060325ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX…
  42. K161062NR Recorder
  43. K771335CREATININE ANALYZER 2
  44. K833568DIATEK 600 THERMOMETER SYSTEM
  45. K760825FUNGAL IMMUNODIFFUSION KIT
  46. K980248ACRI R NEEDLE
  47. K251480PV01 PVDF Effort Sensor
  48. K101700IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
  49. K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
  50. K792192VITA-STAT MODEL 900A
  51. K961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
  52. K191927Hinged Laminoplasty System
  53. K895948PORT-O-SCOPE(TM)
  54. K122439INTELLIVUE PATIENT MONITOR
  55. K823563EEG & RESPIRATION MODULES POLYGRAPH
  56. K093192FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE
  57. K101631FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING…
  58. K833783DISPOS. I/A & IRRIGATION HANDPIECES
  59. K974728INTER-OP METASUL ACETABULAR SYSTEM
  60. K063871D-STAT HANDLE, MODEL 8500-053
  61. K833799SPHYGOMANO METER
  62. K123813VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE
  63. K905018LAB-SITE SAFETY NEEDLE
  64. K203845Philips IntelliSite Pathology Solution
  65. K954826DISETRONIC MULTIFUSE PUMP SYSTEM
  66. K802020PREP SET CAT.#908
  67. K010553PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
  68. K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…
  69. K832903ESOPHOGRAL MULTIPROBE
  70. K130195SCANNING LASERLINK
  71. K051073MIDIVIEW SERIES OF MICROENDOSCOPES
  72. K811178HUMAN IGG-ALBUMIN TEST KIT
  73. K832566COAXIAL ELECTRODE #300A
  74. K232140OTS Hip
  75. K884358CEDIA THEOPHYLLINE ASSAY
  76. K893425VITATRACE
  77. K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)
  78. K900926TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)
  79. K173556Injection Screw
  80. K100508CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
  81. K033004MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY
  82. K083312MINIHIP STEM
  83. K120695DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT
  84. K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…
  85. K231350OCD MT Cap (85-00397-000)
  86. K060026KOBY SURGICAL INTERNAL FIXATION SYSTEM
  87. K012239MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND…
  88. K033780MODIFICATION TO SERAQUEST VCA IGM
  89. K003787NEWTOM QR-DVT 9000
  90. K994387RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL
  91. K113599SURGICASE CONNECT
  92. K240089Face Patches (MT-12MA, MT-12MC)
  93. K854829DENSCO PROPHY PASTE
  94. K211004GMK Spherika Femurs and Fixed Tibial Trays Plus
  95. K213645ClearPoint Maestro Brain Model
  96. K013773SAFE
  97. K910173SELECTRA AND TUBING SETS
  98. K920407DESERET GUIDEWIRE INTRODUCER II
  99. K890553CP&S DISPOSABLE INSTANT COLD COMPRESS
  100. K132099ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND
  101. K862255LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
  102. K253901Millipede88 Access Catheter
  103. K120597KOMPREDA
  104. K900488MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE
  105. K993387IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
  106. K223903Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with…
  107. K833778TESTING VISUAL ACUITY
  108. K841152HOSPAL BIOSPAL SCU/CAVH KIT
  109. K903694AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE
  110. K810562CARBON DIOXIDE (C02) MICROSURGICAL LASER
  111. K131252PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
  112. K790651MODEL WC-3 HEARING AID
  113. K790213GENERATOR, R-WAVE
  114. K140631LUMENA FH HAIR REMOVAL SYSTEM
  115. K173044Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
  116. K800585NSI CHLORIDE REAGENT KIT
  117. K050707LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000
  118. K981239DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
  119. K880734SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
  120. K841194MEDICAL CHAIR, MULTIPURPOSE TAST SUPPORT
  121. K170761LIGHTSonic BUBM
  122. K121427UNIMED TEMPERATURE PROBE
  123. K861983SUTTER LESSER METATARSAL CAP
  124. K873238BRAIN HEART INFUSION AGAR SLANT/GENTAMICIN #T4450
  125. K873963COHERENT XA-30 CO2 SURGICAL LASER
  126. K875206LACTATE DEHYDROGENASE CAT. # 320-68, 320-69
  127. K945059KARL STORZ SUCTION/IRRIGATION TUBES. CANNULAE, SHEATHS
  128. K082769MESA AND RANGE SPINAL SYSTEMS
  129. K040646STRAUMANN GRANULES
  130. K822270VARIOUS TYPES OF ENT ELEVATORS
  131. K792540SONACOLOR 6000
  132. K203791Stainless Turbine
  133. K191313Unity Subcutaneous Infusion System for Remodulin
  134. K911689MODEL 330 SCREENING AUDIOMETER
  135. K993152JEL BIOS 18 (CODE NAME RD- 1214)
  136. K800594VENTRE/SEP CORTISOL RIA
  137. K252946BioBrace® Extra-Articular Ligament Augmentation Kit
  138. K862961MODIFIED SURGICAL STARTER KIT
  139. K993414PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2
  140. K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
  141. K233758Trivicta™ Hip Stem
  142. K761236ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR.
  143. K091070MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
  144. K0937033DI
  145. K061536MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
  146. K870059MENTOR NIPPLE RECONSTRUCTION DEVICE
  147. K143547Vivorte Trabexus EB
  148. K911494NEEDLE CANNULA
  149. K900013MILENIA (TM) DIGITOXIN
  150. K930528A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS
  151. K901952MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL
  152. K061488CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM
  153. K990028ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
  154. K202189Graffiti
  155. K240310LCD Monitors C310S, G310S, C316S, G316S, C616W
  156. K791850ONE-WAY VALVE-FEMALE, M-503
  157. K840536CRYO SURG 5900
  158. K915382AMOENA AFFINITY MODEL #802
  159. K253695LigaMend
  160. K040906CALIBRA CEMENT
  161. K945697SK S-RAY GRIDS
  162. K020546FUSION 7D
  163. K760132TEST, RIA, TSH QUANTIMUNE
  164. K192564Disposable Gold Cup EEG Electrodes
  165. K905203COAGULATION REFERENCE PLASMA, NORMAL
  166. K251195BriefCase-Triage
  167. K192420Crownjun Nylon Suture
  168. K810661CATHDAMP
  169. K760838LACTO-PHENOL COTTON BLUE MOUNTING FL.
  170. K971118ARAGO
  171. K801629COVER-ALL MALE INCONTINENCE DEVICE
  172. K030585SCULPTING RESIN
  173. K130901SOMATOM DEFINITION AS OPEN
  174. K093832LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
  175. K083494ULTIMA FIVE
  176. K243826SMR Reverse HP Shoulder System
  177. K841024VENTREZYME T4U IMMUNOASSAY T4U
  178. K141742ARDO CARUM AND CALYPSO POWERED BREAST PUMPS
  179. K770282WEDGE TIP, SMALL, MODEL #030-191
  180. K201138AMSure® Single Use Saline Topical Solution
  181. K933929LAB-SITE(R) SAFETY CANNULA
  182. K043120MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER
  183. K810581FACT* HOME PREGNANCY TEST
  184. K901152REDYPLATE DISPOSABLE LEG PLATE
  185. K941367WEBB-MORLEY SPINE SYSTEM
  186. K901099PROTOCOL (ALLOY)
  187. K202044Powerpress Recovery Unit
  188. K781253BUN (UREASE) REAGENT
  189. K170666The Wrist-Type Fully Automatic Digital Blood Pressure Monitors
  190. K031435BONESOURCE BVF
  191. K841322OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ
  192. K081267HYGEIA-5 OXYGEN CONCENTRATOR
  193. K932550POWDER FREE EXAMINATION GLOVES
  194. K844020PYRIDOXAL DISC
  195. K011396IBD-CHEK
  196. K791885I.V. START SET
  197. K253094iFuse Bedrock Granite Implant System
  198. K131124COLIGN
  199. K863872TAMPER HAMPER
  200. K182951Pristina Serena 3D
  201. K013229LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
  202. K853194ERA-20
  203. K192188Aquilion ONE (TSX-306A/3) V10.0
  204. K092729BAXANO NEURO CHECK DEVICE
  205. K853235APL HEKTOEN ENTERIC AGAR
  206. K851471TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR
  207. K070376CONMED LINVATEC 300W XENON LIGHT SOURCE
  208. K770017PACING KIT, TRANSMYOCARDIAL
  209. K061899EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
  210. K930301TROCAR SHEATH ANCHOR
  211. K780884HYPO-GRIP
  212. K910217MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM
  213. K933855S490 SEATING SYSTEM
  214. K231458Extremity Staple
  215. K931573VESPHENE II
  216. K831703COVERUPS
  217. K821068DSL 1020
  218. K041572BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML
  219. K192398Millenium HX
  220. K974813COMBISON 530D WITH POWER DOPPLER MODE
  221. K991959PSI TITANIUM ANEURYSM CLIP
  222. K911775OMNICATH IMPLANTED CATHETER AND DEPOT
  223. K884589FRANTZ MEDICAL SHARPS COLLECTOR
  224. K990086HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
  225. K221223extriCARE® 3000 Negative Wound Pressure Therapy System
  226. K925790EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S
  227. K840022HEART CATHETERIZATION TRAY SET
  228. K943520HEPARIN CONTROL KIT
  229. K921374VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER
  230. K832705ULTRAMAX
  231. K032520ORTRAUTEK TRAUMA SYSTEM
  232. K971153SPLITSCREEN (ME-975)
  233. K002443COLLAGEN WOUND DRESSING
  234. K030411PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03
  235. K192987Aina HbA1c Monitoring System 2
  236. K202974DenTek Fresh Protect Dental Guard
  237. K931685FOREARM SELF COMPRESSION PLATE
  238. K092161FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF
  239. K890792POTASSIUM AND SODIUM ELECTROLYTE ANALYZER
  240. K221532PHMB Wound Dressing
  241. K093764SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM
  242. K081089KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY…
  243. K070883DURACON X3 CS TIBIAL INSERT
  244. K811516LEGIONELLA, GROWTH & SELECTIVE, SUPP.
  245. K855065PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE
  246. K802251SP 120 SOPHISTICATE
  247. K173139Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz…
  248. K142558Caspian OCT/MESA Mini/DENALI Mini Spinal System
  249. K893889FD3500 (DENTAL CHAIR)
  250. K923412OLYMPUS LACTATE DEHYDROGENASE REAGENT
  251. K211024Electric Breast Pump
  252. K833254STREPTOCOCCUS ID TRIPLATE SYSTEM
  253. K253089NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122…
  254. K954222VIDEO ENHANCEMENT UNIT
  255. K231613Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B…
  256. K171769Straumann PURE Ceramic Implants
  257. K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP…
  258. K964109MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP
  259. K923927KING DIAGNOSTICS MAGNESIUM REAGENT
  260. K963014SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
  261. K914725COORDINATOR, CABLE INPUT
  262. K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
  263. K811668KULZER TRANSLUX VISIBLE LIGHT CURING
  264. K853652BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT
  265. K033742BOSTON SCIENTIFIC V-18 CONTROL WIRE
  266. K8029256-415 FILTER, ELEMENT, 170-C
  267. K770887AUTO TOTAL PROTEIN FOR ANALYZER
  268. K201669SimpleSENSE
  269. K8134735B SLAVE MODULE SYRINGE PUMP
  270. K070635HEMOSIL PROCLOT
  271. K883810DELFIA TRIIODOTHYRONINE (T3) KIT
  272. K800913GYNECOLOGICAL CYSTO/URETHROSCOPE
  273. K883643TDK ECG ELECTRODE, MEL-10L
  274. K841621BACK RADIUS CUTTER
  275. K760168PENCIL, ELECTROSURGICAL
  276. K940272ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
  277. K100915INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650
  278. K041001OMEGA 2 SYSTEM
  279. K201537Protective Face Mask for Medical Use
  280. K833507PREPARED TRYPTIC SOY AGAR 100 MM PLATE
  281. K113793HOMOCYSTEINE TEST
  282. K081804PIONEER PLUS CATHETER
  283. BK030067Control, hemoglobin
  284. K8737093 RING ATTACHMENT FOR SYRINGES
  285. K982208IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER
  286. K18234814HK701G-W
  287. K981062POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES
  288. K002153ULTRASONIC NEBULIZER, MODEL NE-520
  289. K781152ELECTROCARDIOGRAPHIC ECG RECORDER
  290. K770419CENTURION
  291. K940380AMG MED BRAND CLINICAL GLASS THERMOMETER
  292. BK920005Device, Warming, Blood and Plasma
  293. K771614AUTO. WELL TYPE GAMMA COUNTERS
  294. K904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008
  295. K012736MONOJECT SAFETY NEEDLE
  296. K162183Vantage Galan 3T, MRT-3020, V4.0
  297. K122699SENTRYSUITE PRODUCT LINE
  298. K972233STRYKER WEDGE INTERFERENCE SCREW SYSTEM
  299. K923330THE WESTERN CORTICAL ELECTRODE ARRAY
  300. K033943ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED
  301. K862341TANNING SOFA
  302. K102719ATLANTEAN TRIGGER NEBULIZER
  303. K922678LOOP RETRIEVER
  304. K915678MERIT ADMINISTRATION SET
  305. K820434CLASS OF CASTING ALLOYS TYPE III OR ALT
  306. K964517LINAC SCALPEL FLOORSTAND
  307. K871977DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR
  308. K872444SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL
  309. K860743CAROTID BYPASS SHUNT WITH SAMPLING ARM
  310. K964193CHASE AORTIC ARCH CANNULA
  311. BK920037Media, Potentiating for In Vitro Diagnostic Use
  312. K910723BIODEGRADABLE SURGICAL STAPLE
  313. K030595BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
  314. K932521POWDERFREE LATEX EXAMINATION GLOVES
  315. K103732SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
  316. K915739#903 SILAFLEX II
  317. K964344IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT
  318. K140053KANGLI PEDICLE SCREW SPINAL SYSTEM
  319. K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
  320. K931594THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM
  321. K790205ELECTROAPPLICATOR MODEL C-1
  322. K020414QUANTA LITE CCP ELISA
  323. K120712FORA COMFORTSCAN EAR THERMOMETER
  324. K110796SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE
  325. K772003HUMAN REFERENCE SERUM C4 COMPLEMENT
  326. K221469PATI (Protector Against Tongue Injury)
  327. K082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
  328. K992966REFERENCE
  329. K940402SUPERGEL/SUPPRESSED DUST
  330. K770342RECORDER, CHART, MODEL 5536
  331. K992954KEELER CRYO MASTER & PROBES
  332. K120065PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES
  333. K901451F-20 CEMENTED METAL-BACKED ACETABULAR CUP
  334. K202138Cardiac Trigger Monitor
  335. K090303XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004
  336. K903124LAPAROSCOPIC ACCESS SHEATH SET
  337. K140706LEVO MAX
  338. K812342ZEE EXTRICATION DEVICE
  339. K864104ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST
  340. K951722PERCEPTOR COMPENSATOR MORSE MANIFOLD
  341. K192577Actreen Hi-Lite Intermittent Urinary Catheters
  342. K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…
  343. K890058VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM
  344. K062972PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
  345. K063628CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
  346. K933472SHIMADZU DIGITAL SUBSTRACTION SYST DAR-2400 SERIES
  347. K132316MULTIVIEW
  348. K101413EUROMI EVA SP6
  349. K261866Concerto Versa™ Detachable Coil
  350. K023654GLYCA-DIRECT FRUCTOSAMINE
  351. K782111PADS, MINI, MAXI DEODORANT
  352. K860339PERCUTANEOUS CATHETERS
  353. K853405ELECTROLYTE ANALYZER SERA-252
  354. K192001Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge…
  355. K843164COULTER COUNTER MODEL ZM
  356. K993919DYNATRON 900
  357. K844111DERATA MEDI-JECTOR III
  358. K143758PerioType Rapid
  359. K063295ACON UTI URINARY TRACT INFECTION TEST STRIPS
  360. K101850SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
  361. K771671AUDITORY TRAINER
  362. K163018Zilver 635 Biliary Stent
  363. K926248READER
  364. K873969GIANT RAGWEED ALLERGEN DISC
  365. K941287LIQUID ALT(SGPT) REAGENT SET
  366. K771844WASH SOLUTIONS
  367. K142252XprESS Multi-Sinus Dilation Tool
  368. K854556TRANSFER NEEDLE
  369. K974516ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE
  370. K172393Advisor HD Grid Mapping Catheter, Sensor Enabled
  371. K921843CYNOSURE PHOTODENT, INTRAORAL SURGICAL LASER
  372. K771082DELTASCAN 2000 SERIES
  373. K800920NORDICLAB ESTRADIOL RIA TEST
  374. K003978AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N…
  375. K101059OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE
  376. K042799QRS-CARD CARDIOLOGY SUITE
  377. K955647VIDAS ESTRADIOL II (E2II) ASSAY
  378. K954706KENDALL BLUNT TUOHY EPIDURAL NEEDLE
  379. K963411POSEY LAPTOP TRAYS
  380. K080088BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
  381. K832305SPS DISCS
  382. K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE
  383. K100521COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS
  384. K010878MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
  385. K913018MED-E-JET INJECTOR
  386. K932933GC IV CORONARY GUIDING CATHETER
  387. K910629AP-860PA NIBP MODULE
  388. K230926Ova+ (K-OVAP-USA)
  389. K913197KODAK EKTACHEM DT SLIDES (LAC)
  390. K982883MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
  391. K001763CRIT-LINE MONITOR III (CLM III)
  392. K992133NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT…
  393. K913141MEGA MYELOGRAM KIT
  394. K923065BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL
  395. K845007RFA-7 RADIATION FIELD ANALYZER
  396. K132124KLARITY VACUUM BAG, KLARITY MOLD CUSHION
  397. K141368NEUROPACE BURR HOLE COVER
  398. K892848PANCREATIC A-AMYLASE PNP
  399. K021316ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL…
  400. K954820SCALEX 800
  401. K101540GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
  402. K863731ROTARY* POWERED SCALPEL
  403. K034003HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
  404. K791919BAC JAC
  405. K101926FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
  406. K991470MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060)
  407. K010978TINA-QUANT ALPHA-1 ANTITRYPSIN
  408. K914419AMNIOTEST(TM)
  409. K823546RENAFLO II
  410. K812721DIGITRON
  411. K882322CONTINUUM KNEE SYSTEM (CKS)
  412. K982993PHILIPS OMNIDIAGNOST
  413. K813238NEOCARE BABY-CONTROLLED INCUBATOR
  414. K880202OKAMOTO CONDOMS
  415. K900557MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER
  416. K173085invendoscopy E210 System
  417. K043557MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS
  418. K932338MAGNETOM P8
  419. K090320CONQUEST SPINAL SYSTEM
  420. K850761MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C
  421. K810611FULCAST/SUMMIT CASTING ALLOY
  422. K852164CEDIA TOTAL T4 ASSAY
  423. K902723ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20
  424. K791314VERTEBRACE SPINAL SUPPORTS
  425. K945539OPTIGUARD
  426. K130253TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
  427. K161021HydroMARK Breast Biopsy Site Marker
  428. K103518TRINITY ACETABULAR SYSTEM
  429. K9826383M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S…
  430. K991467K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
  431. K100552RAYSTATION VERSION 1.0
  432. K153625Single Use Injector NM600/610
  433. K013964MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
  434. K051637DSNARE, MODEL 00711087
  435. K232904Access Ostase
  436. K041771TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM
  437. K020732SS MATRIX
  438. K242814Tandry Q-Locking Plate System
  439. K024071GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
  440. K041067HEARTSINE SAMARITAN PAD
  441. K013039INION CPS 2.0 ORTHOGNATHIC PLATE
  442. K251788Extension tube
  443. K141138SURFLASH SAFETY I.V. CATHETER
  444. K832374PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH
  445. K011342COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
  446. K081293UNIVATION UNICONDYLAR KNEE SYSTEM
  447. K081957U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM
  448. K893233DISPOSABLE NEEDLE, ASPIRATION AND INJECTION
  449. K100046M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
  450. K926303ARTHREX INSTRUMENTS (WRIST)
  451. K875030OCU-1
  452. K910873BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
  453. K912446MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2
  454. K092483BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
  455. K904978SOFTWARE PROGRAM USED W/PRISM PRODUCTS
  456. K200294GrandioSO Light Flow
  457. K872539EUROGENETICS CRP ELISA
  458. K915533QUICKIE CARBON WHEELCHAIR
  459. K891378PATIENT EXAMINATION GLOVES (LATEX)
  460. K953406EBI X FIX DYNAFIX SYSTEM (DFS)
  461. K122005MAXLOCK EXTREME SYSTEM
  462. K832545ARTERIAL BLOOD SAMPLING KIT
  463. K802627ORTRON 90* HIP PROSTHESIS
  464. K942755NIL
  465. K03034720.1 MONOCHROME LCD MONITOR, RADIFORCE G20
  466. K871763NEFA STANDARD SOLUTION CALIBRATOR
  467. K070241MODIFICATION TO LAPIDUS PLATE
  468. K242638LED Light Therapy Machine (G1, G3, G4, G6)
  469. K951478GENERAL AND PLASTIC SURGERY PACKS
  470. K062396MODIFICATION TO STOCKERT S5 SYSTEM
  471. K950019THERMOLASE LT-100 ND:YAG LASER HAIR REMOVAL SYSTEM; THERMOLASE LT-100;LT-100
  472. K900018HOLLOW FIBER DIALYZER, BIO CARE PS 130
  473. K913590MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER
  474. K170549TOKUYAMA CUREGRACE
  475. K840624COMBI
  476. K253905PrimeSight UltraView System
  477. K133692IMRI 1.5T AND IMRI 3T S
  478. K912517FLOOR MOUNT TUBESTAND PERFORMER, 6610.101/S-9109
  479. K890963SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4
  480. K020194SIMIDUR KF PLUS
  481. K173982FORTIFY Corpectomy Spacers
  482. K162937Stryker OrthoMap Versatile Hip System
  483. K873141LASER RESISTANT DRAPE
  484. BK940034Kit, Quality Control for Blood Banking Reagents
  485. K915810MER BAG
  486. K884372MADSEN IGO1500 INSERTION GAIN OPTIMIZER
  487. K984235INTERSOURCE 125, MODEL 1251L
  488. K142721cobas MRSA/SA Test
  489. K854530PREMIUM FLEXI-TOUGH
  490. K052958COLOR NIO 2MP, E-2320 C
  491. BK231016Platelet And Plasma Separator For Bone Graft Handling
  492. K061432HOSPIRA ENTERAL FEEDING SET, MODEL 20640
  493. K241285Disposable Endoscope Valves Set (AF series)
  494. K210511InTray GC
  495. K073648GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1
  496. K951843REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT
  497. K914887ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT
  498. K020528INTRASTENT LD (LARGE DIAMETER) STENT
  499. K050775RESSCAN
  500. K211228Rosso
  501. K211697Esperance Aspiration Catheter System
  502. K252221Inset Reverse Total Shoulder System
  503. K212143Neteera 130H/131H Vital Sign Monitoring Sensor
  504. K943993CEDIA DAU AMPHETAMINES ASSAY
  505. K810850PERSONAL MEDICATION INFUSER
  506. K791226PLATELET-CHEX PLUS
  507. K061557FUSION
  508. K940273NOBLES-LAI VIDEO IMAGING SYSTEM
  509. K974160BRUXTRAK MATERIAL
  510. K771061ODUFLEX AEROSOL SET
  511. K840607LF MOTORIZED RADIOGRAPHIC FILM VIEWER
  512. K9742793M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL…
  513. K810800MODEL 230-05 CYBERLITH I BIPOL. PULSE G.
  514. K061581EXCEL HIGH SPEED DENTAL HANDPIECE
  515. K974048INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
  516. K062219PRODRIVE SYSTEMS REPLACEMENT TURBINE
  517. K760437CAUSSE MODIFIED TEFLON PISTON, OTOLOGY
  518. K941208DIAGNOSTIC SLEEVE, REDUCER SLEEVE
  519. K782045MONITOR HS7
  520. K882616ALTERNATE PROCEDURE, PHARMACIA IGE EIA
  521. K212446NuVasive Anterior Cervical Plate Systems
  522. K954595CORDIS BRITE TIP SHEATH INTRODUCER
  523. K953048Z22
  524. K232939IPL Hair Removal Device
  525. K915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE
  526. K243987TriMed Elbow and Forearm System
  527. K241972BLUEDIAMOND IMPLANT
  528. K901955PERIOGARD(R) PERIOPEN
  529. K122013MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M)
  530. K102165STERILE SALINE SOLUTION
  531. K124016EMPI PHOENIX
  532. K965109ELECSYS ESTRADIOL ASSAY
  533. K960957EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK
  534. K844369BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO
  535. K261049SCALA® TL
  536. K905338SIDE PLATE
  537. K970360MITEK SUTURE RETROGRADER
  538. K933949DISPOSABLE ARTHROSCOPIC ACCESSORY
  539. K233112HM70 EVO Diagnostic Ultrasound System
  540. K030756COACH 777-3
  541. K010772ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
  542. K152778TRACOE Cuff Pressure Monitor
  543. K151120Simple T Pediatric Nasal Mask
  544. K000241RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR
  545. K841512ETHOX RELIA-FLO 2001 ENTERAL FEED
  546. K242188ClearRead CT CAC
  547. K023403SPERMGRAD, MODELS 10022/10063
  548. K003523DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
  549. K792061CORDIA RF
  550. K940081MERCURY
  551. K991033ACTIWATCH-SCORE
  552. K960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
  553. K202371Highspeed Airturbine Handpiece
  554. K112463UNITED 36MM CERAMIC FEMORAL HEAD, DELTA
  555. K180956Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator…
  556. K863663OPHTHALMIC SURGICAL OCULAR MARKERS
  557. K952313VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION
  558. K012045HIGHGATE CURVED ROD SYSTEM
  559. K990815COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS
  560. K981168COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS
  561. K860992VOX COMPANION
  562. K061825DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL…
  563. K860704THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND
  564. K032576BIOPSY BREAST COIL, MODEL BBC
  565. K210862Hemafuse System
  566. K131155UGFT3; FHT7
  567. K131729JBAIDS PLAGUE DETECTION KIT
  568. K040077IMMUNICON CELLTRACKS AUTOPREP SYSTEM
  569. K926143ANGIOLAPCATH CHOLANGIOGRAPHY KIT
  570. K935754MURDOCH INTRAOPERATIVE LAPAROSCOPIC LENS CLEANER
  571. K895656ACCU-BEAM WAVEGUIDE
  572. K053530SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM
  573. K963344DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
  574. K781145MONITOR KITS, BLOOD LEVEL
  575. K942928ARGESOL 500
  576. K970839SERVO VENTILATOR 300A
  577. K821263SELECT BIPOLAR COAGULATION FORCEPS
  578. K822873DEVETHERM
  579. K073591MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
  580. K791035FETASONDE FETAL ACTIVITY MONITOR
  581. K020697DEPILASE TWIN YAG LASER SYSTEM
  582. K924710TRIGLYCERIDES
  583. K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
  584. K223272SurBlate Ablation System
  585. K201044CHIRANA Insulin Syringes
  586. K961911DSL ACTIVE I-HCG ELISA
  587. K940607CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM
  588. K890216MICROSURGICAL KERATOME
  589. K955179CONTRAST MEDIA SET
  590. K220022TRATE Dental Implant System
  591. K853916P.M. HIP-FEMORAL PROSTHESIS
  592. K904028DCW MODULAR PROXIMAL FEMORAL SYSTEM
  593. K063448EMG AC/DC SUCTION UNIT
  594. K885001QM300 PCR ANTIBODY PACK
  595. K913459THE E TEST, MODIFICATION
  596. K261935Surgical and Prosthetic Trays
  597. K013775TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
  598. K230066Carnation series Diagnostic Ultrasound System
  599. K791383CANDIDA IMMUNODIFFUSION KIT #CA1001
  600. K915239ENDOPATH DISPOSABLE TROCAR SLEEVE W/DILATING OBTUR
  601. K201689Riptide Aspiration System
  602. K954201BUONAFEDE PNEUMATIC SLEEVE
  603. K010237ELECSYS HCG+B CALCHECK
  604. K003572DYONICS CONTROL RF SYSTEM
  605. K973884ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE
  606. K213278Planmed Verity
  607. K944882IRRIGATION TRAY
  608. K220200Paltop Conical Implant System
  609. K161152Navien Intracranial Support Catheter
  610. K093463AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
  611. K895248IMS5000 ILLUMINATED LOUPES
  612. K190063Servator C SALF Solution
  613. K772086QUANTROLS HCG
  614. K952912SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE
  615. K904128PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER
  616. K000254PAR 5 ACETABULAR COMPONENT
  617. K871851RIBBED CUSHION MASK
  618. K172227Endoscopic Injection Needle
  619. K970349FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667
  620. K112725LIAISON 25 OH VITAMIN D TOTAL ASSAY
  621. K040612SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
  622. K232479ART-Plan
  623. K080338CUTTERSIL ACTIVATOR UNIVERSAL PLUS
  624. K241512Electrode Pad
  625. K850021ELECTROCARDIOGRAPH-ECG CALIPER
  626. K992152GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY…
  627. K890451EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR
  628. K250223BruxZir® Esthetic NOW
  629. K904937PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS
  630. K972708ENDO-SPOR PLUS / HYPROCIDE
  631. K935846MODEL ACUITY CENTRAL STATION
  632. K861091EASISTIM
  633. K870499MCCOY 5A MED (MOD) SUUSPENSION CULTURE, M6523
  634. K252804Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR…
  635. K212472AgeJet
  636. K093975SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009
  637. K853707DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES
  638. K882054HYSTERO KIT
  639. K212551Nitrile Examination Gloves
  640. K884185CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY
  641. K854136ARRHYTHMIA REVIEW STATION
  642. K952574KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING…
  643. K063323SPECTROLYSE PAI-1, MODEL 101201
  644. K013701ENDO-GLIDE
  645. K953395SYNERMED CALCIUM REAGENT KIT
  646. K913546IMPALA CASTERS
  647. K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…
  648. K874735DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE
  649. K940400LYSOL I.C. BRAND DISINFECTANT SPRAY
  650. K941145OXY-GENERATOR
  651. K972395VISTA ANTIGEN SALMONELLA O GROUP D
  652. K802131CYBREX LIDOCAINE
  653. K151136HARMONIC HOOK
  654. K905410OPUS T3 TEST SYSTEM
  655. K800713MJ PERCUSSOR
  656. K000973BEHRING COAGULATION SYSTEM (BCS)
  657. K964402VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
  658. K934206MAVIG ANGIO SHIELD MODELS 6290 & 6272
  659. K864870THUMBSHELPER POWER RING
  660. K921040ENDOSCOPE
  661. K827502MODEL DPS-4050 DIGITAL RADIOGRAPHY SYSTEM
  662. K800919ORAVIEW BY WATER PIK
  663. K132929SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR…
  664. K183357XableCath Crossing Catheter
  665. K811289NOVA 5
  666. K070603C.T.M. MOBILITTY SCOOTER # HS-295
  667. K840638PORTABLE TRANSIT CHAIR
  668. K131542NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC
  669. BK030036Container, Empty, For the Collection '& Processing of Blood/Blood Components
  670. K953062CHERRY DISSECTOR
  671. K9515533I ASYST ABUTMENT PACKAGE SYSTEM
  672. K071875V-CATH POLY PICC
  673. K221943EmbedMed
  674. K110487FLEXIBLE CARDIAC COIL
  675. K954202PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS
  676. K904022NITRO BLUE TETRAZOLIUM REDUCTION
  677. K983271FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS
  678. K110214DIRECTVISION CATHETER, UNCOATED
  679. K923407MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES
  680. K192327DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile
  681. K003033SCAPHIX, STAPLE, FIXATION, BONE
  682. K893694LATEX EXAM GLOVES(MFG: SHANG HAI RONGTONG LATEX)
  683. K032741EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION
  684. K850183CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M
  685. K914549ETHICON ABSORBABLE SUTURE CLIP AND APPLIER
  686. K100335ORS VISUAL
  687. K963036MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
  688. K150200CD HORIZON Growth Rod Conversion Set
  689. K013908WATERLASE MILLENNIUM
  690. K844889MENSINK-GOOSEN CATHETER
  691. K935343CENTRIFIQ BLOOD CONTROL
  692. K991378PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM…
  693. K946031DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING
  694. K894140MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER
  695. K790466U-MAT
  696. K982010FACTS
  697. K770269CAMMADISK DIGOXIN
  698. K884326FILTRAL TM 8 HEMODIALYZER
  699. K080610ARTHROCARE ORTHOWAND SURGICAL DEVICE
  700. K821313SURGICAL UTILITY DRAPE
  701. BK130032Centrifuge, Cell-Washing, Automated for Immunohematology
  702. K911751MEDTRACK TREADMILL
  703. K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
  704. K914726ILT CO2 SURGICAL LASER FOR ORAL SOFT TISSUE PROCED
  705. K140259VARIAX CLAVICLE HOOK PLATE
  706. K250212LapBox Power Tissue Containment System
  707. K880665MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT
  708. K914039SODIUM REAGENT SET
  709. K250989Stryker and Serf hip devices
  710. K0424896F Z4 GUIDE CATHETER
  711. K812530TRANSDUCER DOME
  712. K010583AMBU GEL, HYDROGEL BURN DRESSING
  713. K812159INTRAVASCULAR CATHETER
  714. K900775NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM
  715. K771388AMYLASE ULTRAZYME PLUS
  716. K920001HEMOLAB SILIMAT REAGENT
  717. K212975MedWand
  718. K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
  719. K091690SHARP CHUTE
  720. K180479ReDS System
  721. K160136Flowable Wound Matrix
  722. K953455OPUS B12
  723. K881496LINDER NASOTRACHEAL AIRWAY
  724. K850529SHEER ADHESIVE BANDAGES, STERILE
  725. K831657ALKA FIRST AID KIT
  726. K092214CHIROPRO L SYSTEM
  727. K240685Salvo® Spine System
  728. K771936MICROBIOLOGICAL CULTURE MEDIUM
  729. K172571ULTRASCORE Focused Force PTA Balloon
  730. K801326ANSPACH OPERATING TABLE SUPPORT/SPINAL
  731. K233372KARL STORZ Fiber Telescopes for Urology
  732. K840704SECURE W/35MM DIAM, SHEATH/ADHESIVE
  733. K021103MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
  734. K162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
  735. K790181SOFT SPLINT STRAPS
  736. K870856COSMOS
  737. K181517Senhance Surgical System
  738. K925424MEDICAL MANUFACTURING INC GAS SAMPLING LINES&CONN.
  739. K202152NextAR TKA Platform
  740. K161271da Vinci Xi Surgical System
  741. K891250BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC
  742. K901351SEARS MODEL 9098 ITE HEARING AID
  743. K850792ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP
  744. K962746CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT
  745. K913238ALWAYS, UNSCENTED MENSTRUAL PAD
  746. K960388DYNAREX NON-WOVEN SPONGE
  747. K904826TKO TELESCOPING LITHOTOMY STIRRUP
  748. K930156MEGA PLUS SUPER LAG SCREW
  749. K082902RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES
  750. K213778IV Administration Set
  751. K872815TRANSJAW(TM)
  752. K945094HNR-PC HIP
  753. K951081OB/GYN PACKS
  754. K210823LYMA Laser
  755. K934259AC-POWERED MEDICAL EXAMINATION LIGHT
  756. K901535MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
  757. K852428MANAN EPIDURAL NEEDLE
  758. K771413LIGACLIP MULTIPLE LIGATING CLIPS
  759. K030250IGLIDE MANUAL ASSIST WHEELCHAIR
  760. K905526AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR
  761. K961196EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
  762. K240208DESS Dental Smart Solutions
  763. K210951Leonardo Mini Blue
  764. K222024Evita V800, Evita V600
  765. K251613SwissGraft X
  766. K994438BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
  767. K110146NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
  768. K853739SONOLAYER SAL-55A/55AS
  769. K252862Electric Wheelchair (DH01126)
  770. K213745Air Compression Therapy Device, model: ST-502
  771. K953901SARNS 800 ROLLER PUMP
  772. K946231EYE COOLER
  773. K833724ENZYMATIC CO2
  774. K931541MODEL 26-0375, ELECTROSURGICAL GENERATOR
  775. K770517NF DEVICE
  776. K920162TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK
  777. K962603MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES
  778. K951105KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
  779. K910189PERFOURM PUTTY SOFT
  780. K242924OPXION Optical Skin Viewer (OPXSV1-01F)
  781. K926450EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH
  782. K905327MAXIGOLD
  783. K982245TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE…
  784. K811023ROOT CANAL KIT
  785. K972705RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC
  786. K895443MODEL 210 IMPEDANCE SYSTEM
  787. K031581NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE COLOR, WITH…
  788. K122839ZOLL SUREPOWER SINGLE BAY CHARGER
  789. K131876M SERIES PATIENT MONITOR
  790. K943863NEEDLE GUIDE
  791. K831568RELIANCE TEMPO OPHTH. INSTR STAND
  792. K961636MEDILOG VISION
  793. K253072Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21…
  794. K862994PORTABLE ISOKINETICS 3002 ISO KANE II
  795. K831740DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE
  796. K922575ALWAYS CONTOURS UNSCENTED MENSTRUAL PADS
  797. K230580Diode Laser System
  798. K842013SIGMA PROCEDURE 47-UV
  799. K212478Dermatological diode laser system
  800. K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS®…
  801. K092860LASEMAR 800, 1000, 1500
  802. K063254THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
  803. K910436ELASTIC ADHESIVE BANDAGE
  804. K090738THERMOFLO HCH, THERMOFLO FILTER
  805. K941247VIDENT IMPAC INFINITE POSITION ABUTMENT
  806. K960311PERINEOMETER
  807. K860805PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337
  808. K972701BARCO MWD 321 MEDICAL WORKSTATION DISPLAY
  809. K072362NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG
  810. K920120ND:YAG SURGICAL LASER
  811. K961169RHEUMATOID FACTOR LATEX SLIDE TEST KIT
  812. K150347Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+
  813. K884947HAND HELD NEBULIZER SYSTEM
  814. K970488HYDROCHECK MICRO FILTER
  815. K130606FMWAND FERROMAGNETIC SURGICAL SYSTEM
  816. K083297PITT-EASY DENTAL IMPLANT SYSTEM
  817. K902279KM-5 METAL BACKED ACETABULAR CUP
  818. K934279PHX TECHNOLOGIES CORP., 5MM, 10MM, AND 12MM BLUNT-TIPPED TROCAR OBTURATORS AND MATCHED…
  819. K150983Pyrenees Cervical Plate System
  820. K981684STEALTHSTATION TREATMENT GUIDANCE PLATFORM
  821. K770673COLLECTOR, SANI-CATCH, NO. 1014
  822. BK130001Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
  823. K791672ALBUMIN INTRAVENOUS ADMINISTRATION SET
  824. K262622Swoop® Portable MR Imaging® System
  825. K121656GEMINI LITHOTRIPTER
  826. BK960020Kit, Quality Control for Blood Banking Reagents
  827. K140886WALKAIDE SYSTEM
  828. K931459KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER
  829. K063152CLAROS DENTAL LASER SYSTEM
  830. K152739Electronic Thermometer
  831. K874469TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)
  832. K242463ARIA Radiation Therapy Management System (18.1)
  833. K971947INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER…
  834. K191522Straumann Modular Cassette
  835. K883118ON THE SPOT CANDIDASURE
  836. K181859Visualase Thermal Therapy System
  837. K182915ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube
  838. K171798Silverwear Silver Pro Garment Device
  839. K043361ACCUHEART ELECTRODE BELT
  840. K791912IMV FOR MONITORING #M-510
  841. K914150JANSEN-ANDERSON INSEMINATION SET
  842. K110805GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
  843. K113731ESENSOR RESPIRATORY VIRAL PANEL
  844. K183395Arthrex 2.5 mm Tenodesis Screw
  845. K030133SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH…
  846. K023860MICROALBUMIN REAGENT SET AND CALIBRATORS
  847. K261626UltraPrint Flexible Denture UV
  848. K110288FEMVUE SALINE-AIR DEVICE
  849. K870629CALCIUM TEST
  850. K113362SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
  851. K821044PATIENT PREP KITS/TRAYS-STERILE
  852. K052847CAPLESS PEDICLE SCREW SYSTEM
  853. K040477MONODERM
  854. K910127SUNGLASSES, NON-PRESCRIPTION (POLINELLI)
  855. K120600DURAGEN SECURE DURAL REGNERATION MATRIX
  856. BK960030Blood Establishment Computer Software and Accessories
  857. K102441NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN
  858. K050145CELLTRACKA ANALYZER II
  859. K950516COLDCIDE-10
  860. K85146876 EMA LINING CEMENT
  861. K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…
  862. K884111PUMPETTE(TM)
  863. K191919Elos Accurate Hybrid Base
  864. K954810MYERSON IR DENTURE BASE
  865. K091578LIFT CHAIR, MODEL T3
  866. K821407DEVA M
  867. K770263DIALYSATE METER RS-2100A, CIRCUIT CHANGE
  868. K951054XCEL SLIT LAMP
  869. K896962TINY HALOGEN EXAM LIGHT
  870. K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
  871. K072365SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM
  872. K170824BD Vacutainer Eclipse Signal Blood Collection Needle
  873. K924241ARGENCO 75M
  874. K822036VOLU-SOL DECALCIFER
  875. K001972ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK
  876. K213498PELNAC Meshed Bilayer Wound Matrix
  877. K852421SENTRY II NONINDWELLING BLOOD PRESSURE MONITOR
  878. K110776DIGITAL THERMOMETER MT SERIES
  879. K040212TRIGEN INTERTAN
  880. K882029LABELING FOR REVISED PASCO MIC AND MIC/ID PANELS
  881. K900332EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE
  882. K090397XPI ANGLED ABUTMENTS
  883. K761315ALKALINE PHOSPHATASE (ALP)/PNPP
  884. K973896OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
  885. K202663Suture Wing
  886. K250657gi2000 Electrosurgical Generator
  887. K862876NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM
  888. K992483MEDIFIX INC.
  889. K162403HyperBand
  890. K820526RELIEF VALVE-HONAN INTRAOC. PRESSURE
  891. K840294GROUP A SELECTIVE AGAR W/5% SHEEP BLOOD
  892. K011788EVERSTICK
  893. K2022563Shape Implant Studio
  894. K802103ECG RECALL & EDIT PRODUCT VERSION-A3601
  895. K120060E-CUBE 9
  896. K841440ND62T THYROID UPTAKE SYSTEM
  897. K912097AUTO SUTURE ENDOSCOPIC FASCIA STAPLER
  898. K023668JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA…
  899. K031560BAYER RAPIDLAB 1200 SYSTEM
  900. K023889WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
  901. K831785NEURO EASE
  902. K890185C-S IMPACTOR
  903. K992186QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT
  904. K920319SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI
  905. K032175DESENS-IONOMER
  906. BK130046Test, Qualitative, for HLA, Non-Diagnostic
  907. K760750STERILE TUBULAR UNBLEACHED STOCKINETTE
  908. K951907NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER
  909. K153127everX Posterior
  910. K123540SYNGO CT PULMO 3D
  911. K003481CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660
  912. K020152SYNTHES VERTEBRAL SPACER TI
  913. K945685KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
  914. K893031DELTA (TM) ROBOTIC PIPETTOR
  915. K093050ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
  916. K110954ARJORAD STERILE WRAP
  917. K933897PHX TECHNOLOGIES CORP., 5MM DISPOSABLE SUCTION-IRRIGATION CANNULA CLEANER
  918. K040729SOLARIS D890 THERAPY PROBE
  919. K142805Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug…
  920. K113616ACCUDXA2
  921. K171005Silhouette Featherlift
  922. K003554HARDYDISK TRIMETHOPRIM 5MCG
  923. K162991YELLOW 560 Fluorescence Module
  924. K211459syngo.via MI WorkFlows, Scenium, syngo MBF
  925. K121510IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER
  926. K771642ADAPTER A-413
  927. K040098VARNISHAMERICA
  928. K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…
  929. K862506THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR
  930. K911524PALFIQUE ESTELITE
  931. K862793MP-066-M RADIOAEROSOL KIT
  932. K221525PreXion3D Explorer PRO
  933. K94162840 MICRON BLOOD TRANSFUSION FILTER
  934. K900892MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE
  935. K802764PLASTIC ADHESIVE BANDAGE
  936. K032235MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
  937. K781538SINGLE VIAL LDH-L TRIS
  938. K092635ALCATEL-LUCENT TELEHEATH MANAGER
  939. K141842STARBAND, STARLIGHT
  940. K911358CMD/DLCO DIAGNOSTIC SPIROMETER
  941. K072338CERVITEC PLUS
  942. K102098POWDER FREE VINYL PATIENT EXAMINATION GLOVES
  943. K873502SCISSOR, RIGHT
  944. K013980SAFE SHIELD PRE-POWDERED LATEX EXAMINATION GLOVES
  945. K893822HONYEE VINYL EXAMINATION GLOVES
  946. K973578INVOTEC EAR TAMPON (WICK) W/STRING
  947. K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban…
  948. K823076SATOBAN FIRST AID TAPE
  949. K945065DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
  950. K853539ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT
  951. K951911GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)
  952. K171939ALVUE Balloon Dilation System
  953. K062231MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001
  954. K080786ML830TP
  955. K052554MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR
  956. K840887AMRESCO E2A REAGENT SET 0562 & 0626
  957. K994233AT HOME DRUG TEST, MODEL 9068
  958. K173803Omnican fine
  959. K984302OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS
  960. K092435VERSEO AIR PRESSURE MASSAGER
  961. K132297EM SINUS DILATION SYSTEM
  962. K981919BISSINGER CABLES, CAT. NO. 801000XX
  963. K041842NORIAN SRS FAST SET PUTTY
  964. K903905SERIES 9000 LIFT-RECLINE CHAIR
  965. K823646FRICTION FEEDER
  966. K133829AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2&…
  967. K001497MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)
  968. K052716RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
  969. K033320SCOUT PRO
  970. K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
  971. K010328MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
  972. K213370VERIQA
  973. K013489KP + LFM
  974. K132995DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP…
  975. K925261NUTRICARE ENTERAL FEEDING TUBE
  976. K834069ARTHROSCAN VIDEO SYSTEM
  977. K904993LAPAROSCOPIC ELECTROSURGICAL DEVICE
  978. BK070003Blood Bank Supplies
  979. K113687EQUINOX RELIEVE
  980. K880609ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM)
  981. K052744C2000 AUTOMATED MANIFOLD KIT
  982. K213848Medical nitrile examination gloves (Model: JL001)
  983. K113121COMPREHENSIVE REVERSE SHOULDER
  984. K252841REAL INTELLIGENCE™ CORI™ XT (CORI XT)
  985. K905495HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR
  986. K050217FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE…
  987. K053032ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000
  988. K170292Tri-Ex Extraction Balloon With Multiple Sizing
  989. K072153QUICKIE QX MANUAL FOLDING WHEELCHAIR
  990. K761332HI-SENSITIVITY MODE OPTION FOR S60-1A
  991. K192195Sterile Dilator
  992. K872897TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA.
  993. K141365OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
  994. K052463PROMETAL HN86
  995. K221277Mygen M-3004 RF Generator M-3004
  996. K111091MERIT MEDICAL 20 ML SYRINGE
  997. K855048NORELCO DIGITAL BLOOD PRESSURE METER HC3001
  998. K843441URINARY DRAINAGE CONTAINER 2012-WITH
  999. K112975CARBONAID C02 DIFFUSER
  1000. K832105ADMINISTRATIVE IV SET

About this dataset

A 510(k) is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Source: U.S. Food and Drug Administration (FDA), 510(k) Premarket Notification database