FDA 510(k) clearances — page 968
clearances on record, most recent first.
Clearances — page 968
96,701–96,800 of 175,890- K962633 — VEGA HEMATOLOGY ANALYZER
- K962668 — AMR-ACV CLAMPS
- K962690 — E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE
- K962987 — EZ-FIX SMALL CANNULATED SCREW SYSTEM
- K963048 — IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
- K963060 — HEELBO SECURITY BELT
- K963061 — IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
- K963095 — TRUPEAK PEAK FLOW METER
- K963187 — MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
- K963402 — INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER
- K963901 — ELECTROSURGICAL PROBE
- K964115 — RESOUND CC4 PERSONAL HEARING SYSTEM
- K943824 — GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
- K961272 — NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
- K961705 — AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM
- K961710 — AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM
- K961836 — MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
- K961935 — SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER
- K962028 — WELLCOLEX E-COLI OI57 ZC60
- K962081 — COMBILINES HEMODIALYSIS BLOOD TUBING SET
- K962083 — KARL STORZ REMORGIDA FORCEPS
- K962482 — SCUBA SYSTEM
- K963025 — SLEEPNET HUMIDIFIER,(84200 PACKAGED)
- K963034 — FEMTEX GENTLE TOUCH TAMPONS
- K963035 — MICRO SPIROMETER
- K963042 — INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853
- K963046 — ENDOCAM
- K963099 — HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET
- K963199 — HEELBO PELVIC RESTRAINT
- K963550 — RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM
- K963911 — ALPCO/MERCODIA INSULIN ELISA
- K964027 — STP SYSTEM-PVA WITH MERCURY
- K964053 — HEMOCUE GLUCOTROL
- K960590 — TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE
- K961361 — ASTA-CATH
- K961364 — AUTOMATIC TUBING CLAMP SYSTEM (ATC)
- K961621 — THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM
- K961645 — MRS-2D
- K961784 — COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS
- K962764 — NEUROMAG-122
- K962993 — CYNOSURE PHOTOAPPEAL CO2 SURGICAL LASERS
- K963041 — HEELBO LIFE JACKET WITH CROTCH SUPPORT
- K963233 — EZ-SCREEN PROFILE
- K963274 — V-LINK 3.2 FOR WINDOWS
- K963292 — COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
- K963393 — MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT
- K963419 — MORRISON MEDICAL WRIST RESTRAINT
- K963527 — UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS
- K963766 — 3M PROPLUS SYSTEM
- K954850 — BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR
- K962726 — BARD QUANTUM CVR
- K962795 — CEDIA DAU OPIATE 2K ASSAY
- K962988 — COULTER GEN-S SYSTEM
- K963188 — DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
- K963218 — BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE
- K963367 — RMS K-WIRE
- K963516 — VERDICT THC
- K963529 — VERDICT BARBITURATES
- K963543 — SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2
- K963602 — BIODERM PVP FOAM WOUND DRESSING
- K963606 — VISUALINE COMBO V (COCAINE/THC) TEST
- K963666 — INSTANT COLD PACK
- K963816 — LEVO COMPACT LC
- K963827 — AXSYM FREE TRIIODOTHYRONINE (FREE T3)
- K963833 — IMX FREE TRIIODOTHYRONINE (FREE T3)
- K960431 — PRESSURE STOPCOCK/MANIFOLD
- K961595 — DEFIBRILLATOR ANALYZER, DELTA 1000
- K961598 — ELS AUTOMATIC TUBING CLAMP SYSTEM
- K961833 — SONOLINE ELEGRA WITH SIESCAPE FEATURE
- K962158 — PICO MODELS 30, 50, 70
- K962178 — BARD TIGER GUIDEWIRE MODEL 000540
- K962269 — CEDIA CARDIAC TDM MULTI-CALS
- K962292 — HEARSAVER
- K962724 — STERILE LATEX SURGICAL, SOLD UNDER BRAND NAMES SAVACARE AND ROGUMED
- K962859 — MINI SAMPLE PROCESSOR
- K962892 — HELAX TMS BRACHYTHERAPY, VERSION 3.0
- K963144 — GC BASELINE
- K963205 — ALGINMAX, ORTHOCHROME
- K963306 — CEDIA N-ACETYLPROCAINAMIDE ASSAY
- K963378 — MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER
- K963504 — MEDLINE OPEN END FINGER CONTROL MITT
- K963528 — ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)
- K963533 — SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1
- K963751 — PT SYNTHETIC MEDICAL GLOVES, POWDER FREE
- K963797 — PM SYNTHETIC MEDICAL GLOVES, POWDER FREE
- K954448 — VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
- K954788 — EUREDUC PNEUMATIC DRAINAGE SYSTEM
- K960299 — PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE
- K960968 — MEDI-TRACE 200, MEDI-TRACE 200-30
- K961054 — SYSMEX UF-100
- K961341 — CONVERTORS POLYOLEFIN FABRIC GOWNS
- K961425 — BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS
- K961426 — BIO BOOST
- K961432 — RADIAS GALT TEST
- K961677 — ACUPUNCTURE NEEDLES
- K962190 — PATELLOFEMORAL JOINT PROSTHESIS
- K962714 — PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000
- K962955 — GAMMACON IMAGE TRANSLATION SYSTEM
- K962967 — FUJI MEDICAL DRY IMAGER FM-DP 2636
- K963026 — TBD
Data sourced from openFDA. This site is unofficial and independent of the FDA.