FDA 510(k) clearances — page 1215
clearances on record, most recent first.
Clearances — page 1215
121,401–121,500 of 175,890- K904883 — OPTYX
- K904899 — VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR
- K910229 — SOFT TISSUE SUTURE WASHER/3 HOLE WASHER
- K910492 — BARD REPLACEMENT GASTROSTOMY TUBE
- K910634 — DC200 DEFIBRILLATOR
- K910652 — SPINAL TAP NEEDLE
- K910905 — SFA-II MICROPROCESSOR-CONTROLLED MODULE
- K911417 — ICON STREP B IMMUNOENZYMETRIC ASSAY
- K911640 — OLYMPUS PK TP(TM) SYSTEM, MODIFICATION
- K911740 — SALTER LABS NEONATAL NASAL OXYGEN CANNULA
- K911897 — GASPARAITIS ESOPHAGRAM CATHETER SET
- K912061 — HEPARIN ADSORBENT
- K912174 — SALTER LABS DISPOSABLE NIPPLE AND NUT
- K912208 — FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
- K912256 — PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT
- K912316 — QUIKPAC-II ONE STEP PREGNANCY HOME TEST
- K912395 — HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT
- K912408 — MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA
- K912473 — ACCU-PLACER TM KIT
- K912488 — FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
- K912489 — COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
- K912665 — SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID
- K912940 — COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA
- K911825 — TRIP(TM) NASOGASTRIC SUMP CATHETER
- K911827 — MODEL 5866-9M & MODEL 6981M
- K912542 — PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS
- K903734 — ADVANTAGE EP
- K904918 — BELSCOPE LARYNGOSCOPE
- K905168 — HYPERLITE
- K905435 — UNIQUANT
- K905633 — HUMAN C-REACTIVE PROTEIN RID KIT
- K905752 — ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE
- K910002 — GENESYS AND THE ROI
- K910169 — FETALGARD 2000
- K910648 — THERAPY CHAIR SYSTEM
- K910895 — SURGICAL GLOVES
- K911216 — INFUSABLE
- K911358 — CMD/DLCO DIAGNOSTIC SPIROMETER
- K911853 — PULSATILE ANTI-EMBOLISM SYS.PUMP
- K911935 — CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
- K912007 — BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF
- K912225 — 3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT
- K912234 — SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION
- K912680 — ANTIGENZ CHLAMYDIA
- K912729 — EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)
- K912733 — AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT
- K912723 — POSEY CUFFLATOR
- K905802 — CENTAURI/PEGASUS
- K911787 — MONOPOLAR SPHINCTERTOME
- K911794 — CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE
- K911813 — ENTREE CANNULA
- K911826 — IMMUNOCARD HCG ONE STEP (I-S) TEST KIT
- K911838 — ROCHE REAGENT FOR C02
- K911873 — X-MARX
- K911943 — CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM
- K911955 — OLYMPIC WARMETTE
- K911991 — MAGNETOM P8 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K912024 — AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)
- K912246 — TARGET MICROALBUMINURIA TEST
- K912380 — LASER BEAM LOCALIZER FOR SIREMOBIL 4
- K912513 — ELECTROLYTE CONTROL
- K912543 — MICRO ALBUMIN EIA TEST KIT
- K912633 — SALTER LABS INFANT MEDIUM CONCENTRATION MASK
- K912761 — SURGICAL SAW BLADES
- K912797 — PERRY NATURAL POWDER FREE GLOVES
- K903512 — FUTURECARE CARELYNK IV SYSTEM
- K904966 — DATAMED MODEL 401A TRANSRECIEVER
- K910001 — MODEL 8604-FO PULSE OXIMETER
- K911382 — IPI ALGO-LINE CATHETER
- K911549 — INJECTOR FILL TUBE
- K911906 — MAGNETIC HDL CHOLESTEROL TEST
- K912251 — KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST
- K912536 — CALCITONIN KIT MITSUBISHI YUKA
- K912762 — K-CAP-I, STERILE
- K903237 — CARDIOCAP CMX-104 MONITOR
- K903660 — DERMALIGHT PSORACOMB
- K904448 — TOWNLEY TOTAL KNEE (TTK)
- K905274 — VITALMAX 2100/2200
- K910144 — 12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON
- K910808 — Q-SMART HOLTER SYSTEMS
- K911214 — NUTIP (TM) SYRINGE SHIELD
- K911240 — HEPCON HMS WITH BODY SURFACE AREA CALCULATION
- K911278 — OLYMPUS AF ANGIOSCOPE SYSTEM
- K911301 — VZV IGM TEST
- K911418 — GUM MASSAGER
- K911459 — GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING
- K911500 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH
- K911501 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX
- K911624 — VISION BG TEST STRIP
- K911682 — AIRSTRIP FIRST AID & POST-OP DRESSING
- K911754 — SCISSORS,GRASPERS,FORCEPS
- K911866 — TRACE TOTAL/DIRECT BILIRUBIN REAGENT
- K911917 — CODMAN PEDIATRIC HORSESHOE HEADREST
- K911918 — SWIVEL HORSESHOE HEADREST
- K911994 — HEMOCHRON(R) APTT, MODIFICATION
- K911995 — PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION
- K911996 — SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
- K911997 — TENDERFOOT(R), MODIFICATION
- K912133 — PX COULTER(R) CELL CONTROL
- K912135 — XY IMAGING TABLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.