FDA 510(k) clearances — page 905
clearances on record, most recent first.
Clearances — page 905
90,401–90,500 of 175,890- K980703 — PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
- K980777 — DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING
- K980827 — LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
- K963364 — GLASS VAN GLASS SYRINGES
- K971994 — B-D ASSURE EAR THERMOMETER
- K974456 — CMVGEN
- K974649 — BIO-POST DENTAL POST SYSTEM
- K974711 — COAMATIC PLASMINOGEN
- K974883 — BACTEC MGIT 960 SYSTEM
- K980046 — BRONCHIAL CATHETER SYSTEM
- K980096 — OAC (OPTICAL ASPIRATING CURETTE)
- K980206 — IMMULITE ANTI-TG AB
- K980384 — TRIP TONOMETRY CATHETER, 18F
- K980385 — DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES
- K980393 — SOPRANO CRYO-THERAPY SYSTEM
- K980508 — KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400
- K980510 — KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)
- K980598 — EBNA-1 IGM ELISA TEST SYSTEM
- K980633 — ENDOSOLV E
- K980640 — HEELBO WAIST AND CHEST VEST
- K980650 — REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL
- K980661 — CERA E DENTAL ALLOY
- K980683 — TROVAFLOXACIN 10G, SENSI-DISC
- K980815 — ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
- K980833 — IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
- K980852 — GII SPINAL FIXATION SYSTEM
- K980965 — SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL
- K980985 — SCMD-1000
- K981192 — MG
- K981218 — CREATINE KINASE (CK)
- K981241 — IRON
- K981270 — IRMA BLOOD ANALYSIS SYSTEM
- K981276 — N-ASSAY L D-BIL
- K981282 — ELECSYS AFP
- K981336 — TBIL
- K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
- K981368 — PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS
- K981382 — PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS
- K970098 — E100 SERIES SPO2 SENSORS
- K970139 — MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO
- K970211 — MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR
- K970460 — NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
- K971377 — GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE
- K972419 — TOENNIES NEUROSCREEN SYSTEM
- K972705 — RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC
- K973170 — SIS WOUND DRESSING
- K973335 — QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
- K973741 — BAIR HUGGER BLOOD/FLUID WARMER
- K973834 — CS2000 & CS2000 TOMO
- K974438 — MEDRAD ATD-T INTERFACE DEVICE
- K980383 — MOOORLDI LASER DOPPLER IMAGER
- K980399 — PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20
- K980400 — PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
- K980437 — SILICONE PUNCTAL PLUG
- K980441 — SPIROMETER MODEL NPB-500
- K980443 — PEAK FLOW METER MINIMAX
- K980483 — MENTOR SUSPEND SLING
- K980534 — DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H
- K980568 — JUMBO GLASS IONOMER CEMENT
- K980616 — PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)
- K980623 — N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE
- K980922 — PROTEC CEM.
- K981023 — KLEENASEPTIC
- K981280 — CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS
- K974674 — CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM
- K980360 — SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES
- K980364 — HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS
- K980373 — ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE
- K980491 — INNOVASIVE LINX TIBIAL LIGAMENT FASTENER
- K980545 — THE NUFFIELD TOTAL KNEE SYSTEM
- K980681 — INNOVASIVE DEVICES MENISCAL SCREW
- K980774 — OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS
- K980776 — ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST
- K980784 — SURETOUCH
- K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING
- K981060 — ABBOTT AXSYM 3RD GENERATION TSH ASSAY
- K981081 — BRIGHTSTAR
- K981248 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
- K981254 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
- K981255 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
- K981274 — ACROMED TIMX PLATE BASED LOW BACK SYSTEM
- K970158 — BABYPAC
- K972996 — EASY ECG PC BASED ELECTROCARDIOGRAPH
- K980346 — ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)
- K980350 — VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150
- K980493 — I.V. CATHETER SYSTEM
- K980549 — OSSEOTITE DENTAL IMPLANT SYSTEM
- K980592 — NTECH CYSTOSCOPES
- K980848 — HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED
- K972894 — AUTOTRANSFUSION APPARTUS (AUTOLOG)
- K973237 — CSS-CARDIOPLEGIA SAFETY SYSTEM
- K974115 — PELVX RING, PELVX RING WITH SUPPORT
- K974116 — PELVX INCONTINENCE RING
- K974117 — PELVX DONUT, PELVX CUBE
- K980054 — PALFIQUE ESTELITE
- K980058 — TOKUSO MAC BOND II
- K980334 — INNOVASIVE 10MM LINX HT LIGAMENT FASTENER
- K980372 — MANAN VS ACCESS NEEDLE/SET
- K980436 — CLASS III REVERSE PULL FACEMASK
- K980583 — EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.