FDA 510(k) clearances — page 834
clearances on record, most recent first.
Clearances — page 834
83,301–83,400 of 176,637- K000351 — HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE
- K000827 — UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
- K000906 — KLINIDRAPE SURGICAL DRAPES
- K000990 — OPUS 10 DENTAL DIODE LASER
- K001078 — SULZER ORTHOPEDICS MS-30 FEMORAL STEM
- K001107 — FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
- K001142 — AUDIO TECHNOLOGIES S:R.1
- K001172 — POLYESTER NONABSORBABLE SURGICAL SUTURES URP
- K001173 — NYLON, NONABSORBABLE SURGICAL SUTURES USP
- K001184 — SILK, NONABSORBABLE, SURGICAL SUTURES, USP
- K001185 — POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
- K001223 — ACULUX, MODEL AX3001, AX3002
- K001274 — LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K001277 — TRIFLANGE ACETABULAR CUP SYSTEM
- K001299 — PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
- K001481 — PALCERAM 49
- K001482 — AURENORM 75 KF
- K001601 — DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES
- K001637 — DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR
- K001640 — BIOSOFT RESIN
- K001643 — VARIS 1.4G
- K001649 — STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234
- K001667 — RESOLVE SURGICAL O.R. TOWELS
- K001672 — POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
- K001686 — GALILEO VENTILATOR
- K993623 — GEMINI E
- K993663 — FIRST CHECK HOME DRUG TEST (THC)
- K994138 — FIRST CHECK HOME DRUG TEST PANEL 3
- K994139 — FIRST CHECK HOME DRUG TEST PANEL 2
- K994238 — IL TEST LIQUID ANTITHROMBIN
- K000959 — CRITERION 60 OR PM 60
- K000978 — ANATOMIC TOTAL KNEE PROSTHESIS
- K000994 — BIPAP DUET LX BI-LEVEL SYSTEM
- K001066 — CD HORIZON ECLIPSE
- K001088 — ULTRASIM CT SYSTEM
- K001215 — DBEST HCG 2 IU/ML TEST KIT
- K001439 — ORTHOCEPH OC100 D
- K990209 — NOVAC7
- K991038 — VASO PRESS DVT SYSTEM, MODELS VP500, VP501
- K994384 — CLICKER
- K994393 — AEQUALIS UNIVERSAL SHOULDER GLENOID
- K001064 — BEHRING COAGULATION TIMER ANALYZER (BCT)
- K001219 — MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM
- K001240 — SERAGARD INJECTION PATCH
- K001269 — DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC
- K001479 — PALCERAM 53
- K001480 — AURECAST 40 B
- K001629 — DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
- K001718 — MILLENNIA ACUPUNCTURE NEEDLE
- K001769 — VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT
- K001786 — TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG
- K992606 — CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
- K994410 — INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST
- K001026 — 3D-MSPECT
- K001067 — DADE BEHRING COAGULATION ANALYZER (BCT)
- K001286 — ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10
- K001303 — BREAST IMMOBILIZATION DEVICE MR-BY 160
- K001311 — SYNTHES (USA) ORIBITAL MESH PLATES
- K001312 — MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL
- K001360 — SIGNUM
- K001477 — AURELUX Y 84 PREMIUM
- K001478 — AURECAST SUPER INLAY
- K001559 — CALCIUM SULFATE PELLETS
- K001711 — M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1
- K001733 — ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES
- K991331 — MEDI-CULT M3 MEDIUM
- K991334 — MEDI-CULT HYALURONIDASE
- K992935 — OCD2001
- K993125 — SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM
- K993176 — MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
- K993625 — INSUFFLATION NEEDLE- 120MM, MODEL 900-200
- K000754 — QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
- K000801 — PC COATED FLUOROPLASTIC VENT TUBES
- K001484 — CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838
- K001567 — ADVANTAGE THC TEST
- K001632 — OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
- K001737 — OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM
- K994239 — ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM
- K000313 — TEARAWAY INTRODUCER SHEATH
- K000433 — PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
- K000543 — CONTEMPRO-MIST
- K000844 — ABSOLUTE HCG PREGNANCY TEST
- K000890 — CHAD THERAPEUTICS OXYMATIC MODEL 401
- K000892 — DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
- K000947 — ULTRASTIM ELECTRODE, MODEL US4040
- K000955 — PLACER MODEL 6232 STEERABLE STYLET
- K000972 — SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
- K000996 — TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
- K001463 — SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156
- K001532 — DYNA-LOK CLASSIC SPINAL SYSTEM
- K001592 — ECHOCOM, IMAGECOM, DOKUCOM
- K001039 — THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
- K001082 — STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
- K001084 — TRANS FX ADJUSTABLE PIN TO BAR CLAMP
- K001545 — PIPET CURET
- K990060 — MACH 7
- K991999 — STERRAD 100S STERILIZER
- K000893 — AC POWERED THERMAL CAUTERY UNIT
- K001068 — NBS CONNECTING TUBE SET
- K001112 — GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC
Data sourced from openFDA. This site is unofficial and independent of the FDA.