FDA 510(k) clearances — page 1018
clearances on record, most recent first.
Clearances — page 1018
101,701–101,800 of 175,890- K931609 — CHARTR ENG SYSTEM
- K943514 — THE HEPANORM HBPM/LMWH KIT
- K943519 — HBPM/LMWH CONTROL KIT
- K943520 — HEPARIN CONTROL KIT
- K944538 — GAS PLASMA STERILIZATION
- K945511 — LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR
- K945914 — BIPOLAR GENERATOR MODEL 2352
- K950716 — THERATEST EL-ANA PROFILES TEST SYSTEM
- K952674 — TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA
- K952885 — SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER
- K953420 — SILK*SKIN SCAR TREATMENT
- K953531 — HOWMEDICA MAINSTAY ANCHOR
- K953556 — VACS TABLE, 9650
- K953557 — SURGICAL C-ARM TABLE, 9610
- K953577 — BARD VISILEX MESH 3 X 6
- K953582 — HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
- K953596 — DISTENDING DIVERTICULOSCOPE
- K953610 — AUKULYTE
- K953804 — VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS
- K953994 — SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM
- K923691 — TWIN SILICONE CATHETER
- K935668 — MEDRAD SPECTRIS MR INJECTOR
- K940820 — PERSHIELD CPR DEVICE
- K941752 — SPECTROLYSE ANTIPLASMIN KIT
- K944449 — EBV-VCA IGM ELISA TEST STSTEM
- K945205 — QBC ACCUTUBE
- K945207 — MECTEST
- K946005 — ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE
- K950143 — ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE
- K951159 — FASGUIDE
- K952114 — KOOL GARD SINGLES GOWN
- K952115 — BARRIER GOWN, KOOL-GARD BACKLESS GOWN
- K952176 — DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K
- K952385 — HEMA-TROL Q-CHECK
- K952756 — MEDI-AID BASAL THERMOMETER
- K952878 — OXY/STAR LOW FLOW BLENDER
- K953084 — ACCESS ULTRASENSITIVE INSULIN ASSAY
- K953239 — BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER
- K953657 — ABBOTT AXSYM PROLACTIN(MODIFICATION)
- K953718 — AXSYM DIGOXIN II
- K953840 — AXSYM PHENYTOIN II
- K954035 — ACTI-FLEX ARTERIAL EXTENSION SET
- K943064 — KIMONO (CONDOMS)
- K946376 — MAXX
- K950276 — MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM
- K950531 — EGNELL ELITE
- K951980 — COLLAPSIBLE HYPODERMIC SYRINGE
- K952159 — BASIS DIGITAL THERMOMETER
- K952835 — WELCH ALLYN VIDEO EPISCOPE
- K952965 — THE TULIP J DISSECTOR
- K953046 — PERI-PUSHER
- K953082 — ILIAC CREST BONE MARROW ASPIRATION NEEDLE
- K953086 — WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA
- K953138 — MEDI-PLUS, HEALTH PLUS, SANITEX, RELIANCE
- K953163 — QUICK READ 2000 (QR2000)
- K953476 — MULTI-PRIME AKA/MONO-PRIME
- K953645 — OLYMPIC PASTEURMATIC SYSTEM
- K953654 — ORS-111
- K953669 — PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSING
- K954033 — TECNOL ISLAND WOUND DRESSING
- K954088 — TELESCOPING PENEVAC
- K954231 — AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
- K926309 — PHOENIX 4.0 MM DENTAL IMPLANT
- K926311 — PHOENIX 4.0 MM ANGLED DENTAL ATTACHMENTS
- K926366 — PHOENIX 3.25 MM C.P. COATED DENTAL IMPLANT
- K926367 — PHOENIX 3.25 MM HA COATED DENTAL IMPLANT
- K926370 — STRAIGHT 3.25 MM DENTAL IMPLANT ATTACHMENTS
- K943180 — INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM
- K945500 — WELLS JOHNSON FIXATION SYSTEM
- K950331 — PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)
- K950803 — ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
- K952058 — STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
- K952160 — INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)
- K952218 — JT-3 ELECTROGNATHOGRAPH
- K952338 — STA-COAG CONTROL [P] PLUS KIT
- K952427 — CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE
- K952592 — OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE INCLINATIONS
- K953023 — PRECEDER GUIDEWIRE
- K953126 — OXILINK (SMALL, MEDIUM, LARGE)
- K953775 — BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE)
- K953836 — ABUTMENT
- K953924 — XLS-300 XENON LIGHT SOURCE
- K954061 — POLY-LITE MODEL 1000
- K935712 — IRON/TIBC REAGENT
- K941252 — RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR
- K942706 — ROCHE CALIBRATOR SERUM
- K951213 — RELAXPLUS
- K952720 — AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
- K952862 — FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR
- K953463 — VACUTAINER PLUS TUBES
- K953739 — ABUSCREEN ONLINE CONTROLS
- K953845 — ABUSCREEN ONLINE DRUG FREE URINE
- K933825 — ADI SYSTEM
- K933961 — MARSAM MODEL 2000 NEBULIZER
- K935730 — EBNA IGG ELISA TEST
- K940320 — AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS
- K942938 — CROSSVENT-4 VENTILATOR
- K944547 — DANTEC KEYPOINT
- K945482 — DISPOSABLE, CPAP OXYGEN MASK
- K945633 — NEURO CHANNEL ENDOSCOPE MODEL 2232
Data sourced from openFDA. This site is unofficial and independent of the FDA.