FDA 510(k) clearances — page 767
clearances on record, most recent first.
Clearances — page 767
76,601–76,700 of 175,825- K020194 — SIMIDUR KF PLUS
- K020195 — SIMIDUR S1S
- K020217 — ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
- K020437 — CLASSIC TENS
- K020536 — GAZELLE WHEELCHAIR
- K020632 — ENGUARD REMOTE PATIENT MONITOR
- K020645 — MODIFICATION TO THE MAESTRO SYSTEM
- K012350 — MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL
- K012448 — VECTORVISION TRAUMA
- K012796 — AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000
- K013089 — EMS HEPA FILTER AND HME COMBINATIONS
- K013123 — EMS PULMONARY FUNCTION TESTING FILTER
- K013572 — MITEK BIOCRYL INTERFERENCE SCREWS
- K014133 — PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
- K014138 — PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
- K014158 — ENDOSCOPIC CAMERA TC804/C4
- K020041 — IALUSET HYDROCOLLOID
- K020142 — MICROSCAN SYNERGIES PLUS
- K020160 — DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
- K020162 — DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN
- K020233 — CHASE CARDIOVASCULAR PATCH KIT
- K020248 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML)
- K020270 — SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA
- K020336 — ENDOSCOPIC CAMERA MC404/C3
- K020451 — COMFORT WHEELCHAIRS
- K012805 — AUTOMARQER
- K012983 — ACIST 4 FRENCH ANGIOGRAPHIC CATHETER
- K012998 — AMPHETAMINE/METHAMPHETAMINE
- K013004 — COCAINE
- K013096 — PHENCYCLIDINE
- K013143 — BENZODIAZEPINES
- K013247 — CANNABINOIDS
- K013314 — OPIATES
- K013492 — IMUBIND TPA ELISA, MODEL 860
- K014230 — STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
- K020015 — IMPLANT GUIDANCE SYSTEM APPLICATOR SET
- K020183 — PISCES PLUS (DW286 C)
- K020190 — PORTADUR P 4
- K020200 — PLAYTEX DEODORANT TAMPONS, MODEL 34802
- K020241 — QACA IGG/IGM ELISA KIT
- K020324 — LIFESTYLE OXYGEN CONCENTRATOR
- K020446 — MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
- K020573 — MODIFICATION TO MAGNETOM RHAPSODY SYSTEM
- K020599 — MTP CLEARVISION DISPOSABLE TUBING SET
- K020606 — NVA-63-8 NEUROVASCULAR ARRAY COIL
- K012045 — HIGHGATE CURVED ROD SYSTEM
- K012575 — PREFERNCE IMRT TREATMENT PLANNING MODULE
- K013109 — SONOPSY
- K014109 — IN-TIME RETRIEVAL DEVICE
- K014164 — GREAT TOE IMPLANT SYSTEM
- K020201 — PLAYTEX DEODORANT TAMPONS, MODEL 34902
- K020202 — PLAYTEX DEODORANT TAMPONS, MODEL 34702
- K020411 — NUVASIVE TRIAD FACET SCREW SYSTEM
- K020480 — RBM
- K020485 — ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
- K020544 — WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
- K020725 — MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1
- K012377 — OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
- K012869 — GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
- K014000 — VISTITOME 20-10 MICROKERATOME
- K014090 — ENDIUS SPINAL FIXATION SYSTEM
- K012960 — BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
- K013005 — ACT 11 MP VENTRICULAR CATHETER
- K013267 — POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS
- K013318 — ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
- K013359 — LP(A)-LATEX SEIKEN ASSAY KIT
- K013662 — MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
- K013677 — MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
- K014052 — EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
- K014053 — CONDUIT TCP GRANULES
- K014054 — EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
- K014057 — DERMASTAR ER:YAG LASER SYSTEM
- K014072 — FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)
- K014263 — NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
- K014286 — SALUTE, MODEL 3022
- K020094 — EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS
- K020100 — SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS
- K020188 — BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR
- K020265 — SERRALENE, MODEL CATALOG NO 1S
- K020391 — STERN MICRO ERA ATTACHMENT SYSTEM
- K020403 — MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR
- K020438 — SAS VALUE HCG
- K020470 — MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE
- K020472 — BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR
- K020594 — DIEGO POWERED DISSECTOR AND DRILL SYSTEM
- K020605 — SANARUS VISICA TREATMENT SYSTEM
- K012506 — MASTERGRAFT RESORBABLE CERAMIC GRANULES
- K012891 — OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)
- K013168 — IMUBIND PLASMA PAI-1 ELISA,MODEL 822
- K014035 — COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS
- K014041 — TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM
- K014075 — BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
- K020158 — NON-EUGENOL TEMPORARY CEMENT
- K020518 — MEDELA SYMPHONY BREAST PUMP, MODEL 024
- K020658 — VIATRONIX V3D COLON
- K012414 — PRIME ECG SYSTEM
- K012957 — TOWEL DRAPE, MODELS 4409, 4410
- K013473 — XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL
- K014111 — REBILDA SC
- K020156 — DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
Data sourced from openFDA. This site is unofficial and independent of the FDA.