FDA 510(k) clearances — page 913
clearances on record, most recent first.
Clearances — page 913
91,201–91,300 of 176,637- 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
- K980660 — BIOGOLD PLUS DENTAL ALLOY
- K980772 — HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
- K980944 — SYNTHES SCHUHLI IMPLANT SYSTEM
- K981098 — STRATUS CS CARDIAC TROPONIN I TESTPAK
- K981102 — STRATUS CS MYOGLOBIN (MYO) TESTPAK
- K981178 — THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
- K981289 — N-ASSAY L T-BIL
- K972911 — AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER
- K972793 — PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE
- K973556 — IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
- K973874 — ACL CLIP-IN PLATE
- K973986 — MECTEST
- K974840 — ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL
- K980276 — STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM
- K980279 — SONY DXC-LS1 COLOR VIDEO CAMERA
- K980282 — URESIL DILATOR WITH RADIOPAQUE MARKER
- K980294 — ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
- K980299 — APEX OXIMETER
- K980322 — ACCENT 16, ACCENT 22
- K980357 — KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
- K980391 — SERAQUEST ANTI-DSDNA
- K980402 — CAPINTEC MODEL 292 ELECTROMETER
- K980557 — SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING
- K980614 — ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS
- K981123 — UREA
- K981222 — DIRECT BILIRUBIN (DBIL)
- K981281 — ELECSYS CALCHECK FERRITIN
- K981436 — DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109
- K965212 — STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM
- K974424 — COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
- K974747 — CS/3 ARRHYTHMIA WORKSTATION
- K980059 — SERAQUEST MUMPS IGG
- K980227 — MANAN GALACTOGRAPHY KIT
- K980376 — THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K980507 — PROSPECT SHIGA TOXIN MICROPLATE ASSAY
- K980516 — REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE
- K980759 — DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
- K981164 — POWDER FREE CHLORINATED GLOVES-(TEXTURED)
- K981221 — ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
- K981225 — ASPARTATE AMINOTRANSFERASE (AST)
- K981278 — ELECSYS CALCHECK CA 125II
- K974598 — MICROKERATOME OR THE MATE
- K980634 — FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
- K980795 — UROLOGICAL BALLOON DILATATION CATHETER
- K980851 — GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028
- K981142 — MAICO MA53
- K981229 — MANAN MANTA CATHETER FIXATION DISK
- K981258 — MANAN MALECOT BASKET DRAINAGE CATHETER
- K981318 — DUAL LUER LOCK CAP
- K964488 — DETACHABLE SILICONE BALLOON (DSB)
- K965071 — DETACHABLE SLICONE BALLOON (DSB)
- K972548 — SLT CL MD CONTACT LASER SYSTEM
- K973896 — OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.