FDA 510(k) clearances — page 1370
clearances on record, most recent first.
Clearances — page 1370
136,901–137,000 of 175,890- K880236 — GLUCOSE HEXOKINASE
- K880238 — TRIGLYCERIDE
- K880242 — KONE CALCIUM TEST
- K880263 — OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION
- K880268 — CO2 REAGENT
- K880307 — ALKALINE PHOSPHATASE REAGENT SET
- K880328 — HCG-NOSTICK
- K880381 — TELOS DISTAL TARGETING DEVICE
- K880395 — TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU.
- K880396 — TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
- K880397 — DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
- K880461 — PERFECTA TOTAL HIP SYSTEM
- K880495 — LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
- K880577 — CONCEP-7-BHCG
- K880628 — TRIGLYCERIDES (GPO-TRINDER)
- K880787 — EASY-TEST LACTIC ACID (LA)
- K880912 — DYNATRON 2000
- K873255 — THE MICRO-VENT/HA
- K874837 — KTP/532 LASER FOR OB-GYN USE
- K875004 — PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
- K875005 — PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
- K875006 — PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK
- K875007 — PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
- K875277 — ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.
- K875309 — SANITARY MENSTRUAL NAPKIN
- K880195 — GYNESCOPE
- K880223 — MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AID
- K880273 — WIDEX HEARING AID MODEL C1
- K880737 — SELF GUIDING (SG) INTERLOCKING NAIL
- K880786 — BUSHLINE CARE CHAIR
- K880800 — GOLDEN POWER LIFT CHAIR
- K880826 — MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM
- K880895 — URESIL WOUND DRAIN TROCAR
- K880986 — MECHANICAL WALKER
- K873150 — PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.
- K874152 — RNP ANTIBODY TEST KIT
- K874195 — LA ANTIBODY TEST KIT
- K874554 — ENVICLUSIVE (TM)
- K874631 — HEALTHPHONE TOCO MODEL
- K874693 — OBT STEREOTACTIC SYSTEM
- K875008 — GUARDALL SHIELD
- K880003 — ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
- K880009 — REVISED LABELING FOR ADX COCAINE METABOLITE
- K880064 — YESNG MODEL 200S11 ELECTROSURGICAL UNIT
- K880073 — YESNG MODEL 500SII ELECTROSURGICAL UNIT
- K880172 — MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.
- K880206 — POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER
- K880253 — BLAKEMORE RETAINER
- K880513 — DISP. NON-MAGNETIC SURGICAL INSTRU. DRAPE
- K880603 — COHERENT XA-40 CO2 SURGICAL LASER
- K880757 — TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD
- K880785 — SKILCRAFT
- K880812 — SPINAL NEEDLE
- K880813 — SELF-RETAINING SOFT TISSUE RETRACTOR
- K874635 — OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
- K875076 — FLORIDA PROBE
- K875238 — SIEMENS NEUROTON 826 AND 827
- K875313 — PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST
- K871744 — CONTATTO CONDOMS
- K872984 — KETAC-CONDITIONER
- K873498 — INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING
- K873807 — AUTOTRANSFUSION APPARATUS
- K875047 — COULTER CLONE T11 MONOCLONAL ANTIBODY
- K875089 — HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN
- K875228 — PERMADYNE ADHESIVE
- K875257 — IMPREGUM F ADHESIVE
- K875383 — LAKE CATHETER CARE KITS (MODIFICATION)
- K880082 — MEMORYMATE HEARING AID MODEL 8200
- K880169 — CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION
- K880179 — BEAVERS' DENTAL DIAMOND INSTRUMENTS
- K880184 — VIBRASOUND IN-THE-EAR HEARING AID
- K880225 — MAGIC EAR MODEL CI IN-THE-EAR HEARING AID
- K880283 — PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS
- K880518 — MOBILE C-ARM OMNI 325
- K880614 — SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
- K880635 — IN THE EAR HEARING AID
- K880664 — MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
- K880683 — KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT
- K875082 — O.P.C. INTRAVASCULAR CATHETER
- K875112 — MENTOR B-VAT(TM) II VIDEO TESTER
- K880024 — TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUS
- K880114 — NUTRIENT BROTH
- K880115 — NUTRIENT GELATIN
- K880464 — DYNATRON II
- K873739 — ACRYLIC IMPRESSION TRAY MATERIALS
- K873853 — DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0
- K873896 — SIMED S-100 PULSE OXIMETER
- K874319 — MONITOR, ELECTROGRAPHIC
- K874383 — MENTOR PLUS (CONDOM)
- K874542 — TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES
- K874594 — TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560
- K874676 — INTERFERENCE SCREW
- K875109 — DETECTADOT SYSTEM 2000 TOXO IGG TEST
- K875195 — OPHTHALMIC LIGHT PIPE PICK
- K875298 — 502-US PULSE OXIMETER
- K880033 — DEGUSTAR
- K880036 — BIOMA 5000
- K880062 — C-MATE #CMU 1001
- K880068 — EFFERVESCENT DENTURE CLEANSER
- K880127 — POTATO DEXTROSE AGAR
Data sourced from openFDA. This site is unofficial and independent of the FDA.