FDA 510(k) clearances — page 1346
clearances on record, most recent first.
Clearances — page 1346
134,501–134,600 of 176,637- K882431 — CONFIDENCE(TM) STERILE, DISP., LATEX SURG. GLOVES
- K883810 — DELFIA TRIIODOTHYRONINE (T3) KIT
- K883933 — INTRODUCING CATHETER
- K884054 — MODIFICATION OF THE CEDIA DIGOXIN ASSAY
- K884081 — INTERIM, TEMPORARY CEMENT
- K884085 — TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
- K884125 — BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403
- K884143 — NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER
- K884207 — RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO
- K884412 — CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.
- K884413 — CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR
- K884428 — ALWAYS UNSCENTED MENSTRUAL PADS
- K884429 — ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD
- K884431 — HEXASCAN HANDPIECE FOR ARGON/DYE LASER
- K884436 — MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85
- K884566 — VISION LYTE (TM) POTASSIUM
- K882177 — ADD-ON TO CRITICAL PATIENT CARE BED
- K882469 — CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES
- K883122 — AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT
- K883752 — ACUSON L538 TRANSDUCER
- K883769 — EXCEL INFLATE-AID
- K883968 — TENDERFOOT
- K884610 — INTERLOCKING INTRAMEDULLARY NAILS
- K884623 — SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE
- K873826 — ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION
- K882406 — CONVA-LIFT
- K882413 — SUBOCCIPITAL ICE PILLOW
- K883177 — H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER
- K883461 — DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES
- K883547 — GE MR MAX SYSTEM
- K883696 — FLO-RESTER
- K883745 — IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
- K883770 — RESUBMITTED EMA DENTIN CEMENT
- K883780 — XTREL, MODEL NUMBER 3425
- K883836 — COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II
- K883941 — PROFORMA HIP SYSTEM
- K883964 — AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
- K884008 — SONY CINE VIDEO SYSTEM SME-3300
- K884056 — MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
- K884302 — EDWARDS ARTHROSCOPIC LEG HOLDER
- K884517 — PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
- K884603 — SHOULDER TRANSMIT AND RECEIVE COILS
- K884604 — MT/S CARLSON SPINE COIL, PART # 100-50082500-01
- K884654 — ALPHACALF SERUM
- K884658 — ZIMMER BEADED THREADED ACETABULAR CUP
- K884694 — MQL 20 ND:YAG OPHTHALMIC LASER
- K884760 — SHOWER CHAIR
- K884783 — RANEY CLIP
- K881140 — ULTRAMARK 4+ ULTRASOUND W/3.5 MHZ 40R CONVEX ARRAY
- K881303 — TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER
- K882751 — GLASS IONOMER BASE
- K882755 — MODEL 500V VASCULAR SPECTRUM ANALYZER
- K883585 — TECHNICON ASSIST POTASSIUM
- K883586 — TECHNICON RA-100 SYSTEM POTASSIUM
- K883698 — ZINC OXIDE EUGENOL TEMPORARY CEMENT
- K883730 — TDX BENZODIAZEPINES SERUM
- K883826 — HOME CLINIC PREGNANCY TEST
- K883867 — CERVICAL BIOPSY INSTRUMENT
- K883889 — TRANSESOPHAGEAL ECHO TRANSDUCER
- K883890 — DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD
- K883891 — DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER
- K883962 — ROCHE REAGENT FOR INORGANIC PHOSPHORUS
- K884138 — ABBOTT IMX LH
- K884168 — ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.
- K884362 — LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD
- K884363 — LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL
- K884364 — LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL
- K884433 — TECHNICON ASSIST(R) CALCIUM METHOD
- K884480 — BIOTROL BILIRUBIN MONOREACTIF
- K882383 — MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES
- K882461 — O2 CARE
- K883704 — MULTIICHALLENGE NEBULIZER SYSTEM
- K883812 — HP-1 (HEALTHPAX)
- K883868 — MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM
- K884369 — POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM
- K884406 — TRACER HIP PINNING SYSTEM
- K884407 — TRACER SKELETAL TRACTION PINS
- K881971 — OCCU-TECH VISION TEST
- K882639 — PALMA
- K883372 — ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
- K883466 — STERILE SURGICAL GLOVES
- K884029 — KTP/532 SURGICAL LASER
- K884656 — DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEP
- K882453 — POLYSCAN DIGITAL SCANNER
- K883202 — ULTRASONIC IMAGING CATHETER
- K883476 — VOXEL FLINGER(TM) 3-D IMAGING SYSTEM
- K883662 — BERICHROM(R) ANTITHROMBIN III
- K884062 — MAGNETOM (M, H, 42, 63) SEQUENCES
- K884148 — DISKCAM DC 6001
- K884188 — NIDEK LM-870 AUTOMATIC LENSMETER
- K884294 — NICOLET NYSTAR PLUS SYSTEM
- K884374 — E.T. PUFFER
- K884541 — PRO-VERTIC 2000 STAND-UP/SELF-RISING WHEELCHAIR
- K884638 — BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR
- K880673 — GHB SAMPLE PAPER
- K881670 — ACCUTEMP PLUS
- K881867 — NEEDLE EJECTOR
- K883212 — LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
- K883694 — TENSIOMETER
- K883703 — MSI-CAL 7
Data sourced from openFDA. This site is unofficial and independent of the FDA.