FDA 510(k) clearances — page 1014
clearances on record, most recent first.
Clearances — page 1014
101,301–101,400 of 176,637- K955097 — AMERLITE MAB FT4 ASSAY
- K955155 — DOCUMENT TDM ULTRA UNASSAYED CONTROL
- K955300 — TOTAL BILIRUBIN PROCEDURE
- K936294 — SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
- K940047 — SPERMICIDALLY LUBRICATED CONDOM
- K945756 — IMAGN(TM) 2000 SYSTEM
- K945930 — RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE
- K952293 — VASCUTEK GELWEAVE VASCULAR GRAFT
- K952922 — BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL
- K953162 — OLYMPUS HIGH FLOW INSUFFLATION UNIT
- K953396 — CARDIOVIT AT-1C, AT-2C
- K953558 — KIS II LG HEX SCREW & CYLINDER IMPLANTS
- K953599 — CLAMP ASSEMBLY
- K954274 — MEPORE (6X7)
- K954327 — MEDOX CHAMPION COMPACT NEBULIZER
- K954398 — INSEMI-CATH II
- K954511 — GO INTRAMEDULLARY NAIL LOCKING SCREW
- K954899 — RIGID NEUROVIEW ENDOSCOPE
- K955321 — PROTEC GAUZE SPONGE
- K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE
- K955359 — CYBER III OPTION UM, UC312, UC10, UCIC
- K950970 — INFUSION SET
- K951600 — MILL-ROSE ROTATABLE POLYPECTOMY SNARE
- K952073 — PACI-TEMP, PACIFIER WITH DIGITAL THERMOMETER
- K952287 — REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT
- K953632 — SERIM PYLORITEK TEST KIT
- K954145 — WAKO AUTOKIT CH50
- K954409 — PS MEDICAL IPI VASCULAR ACCESS CATHETER
- K954439 — ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE
- K954447 — C-REACTIVE PROTEIN LATEX KIT
- K954460 — ILT SURGICAL LASER
- K954566 — SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM
- K954627 — ECTRA II LIGAMENT RELEASE SYSTEM
- K954931 — NEO-MED DLS-1100
- K954933 — EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
- K954965 — ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES
- K955109 — VL2600 HANDSWITCHING PENCIL WITH HOLSTER
- K955467 — NEUROVIEW COAXIAL BIPOLAR ELECTRODE
- K955471 — INCL ENDOSCOPE
- K945066 — AWESMOSIS
- K950042 — SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER
- K950201 — ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER
- K951768 — TEVES ECM PLUS THERMOCOUPLE
- K951938 — SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES
- K952051 — SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES)
- K952154 — SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES
- K952490 — IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM
- K953465 — KENTEMP
- K953866 — MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
- K954092 — ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
- K954316 — AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES
- K954349 — FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS
- K954387 — T CLASS HYPERBARIC FACILITIES
- K954422 — PER-Q-CATH MID-LINE
- K954591 — AIA-PACK CORT ASSAY
- K954700 — ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT
- K954723 — ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
- K954870 — SIMS DELTEC ANTI-SIPHON VALVE
- K955030 — SQUARE ONE SAFETY SYRINGE
- K955049 — OLYMPUS FG-45/46-1 GRASPING FORCEPS
- K955091 — DISPOSABLE POWDER FREE VINYL SYNTHETIC GLOVES
- K943678 — ELECTRONIC FLOW METER
- K953826 — ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA
- K954140 — MASTERSCREEN IOS
- K954340 — STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE
- K954846 — OLYMPIC SMART SCALE
- K955127 — HANYANG SUNGLASSES
- K955177 — OLYMPIC SMART SCALE
- K935585 — APR ACETABULAR INSERTS IOI BIPOLAR
- K950565 — DEROYAL SURGICAL INSTRUMENT DRAPE
- K952298 — SPINAL PEDICLE SCREW, FIXATION, APPLIANCE
- K952645 — VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE
- K952766 — RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)
- K952860 — THE NINER NITINOL GUIDEWIRE
- K953120 — VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE
- K953731 — PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION)
- K954300 — ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY
- K954554 — ALTA TIBIAL/HUMERAL ROD
- K954630 — DEPUY TITANIUM CROSS PIN FIXATION SYSTEM
- K954697 — CIBA CORNING ACS ESTRADIOL-6 ASSAY
- K954799 — ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
- K954809 — UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494
- K954993 — QUIX RAPID PREGNANCY STRIP TEST
- K955001 — EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS
- K955042 — CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM
- K955089 — ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT
- K955100 — CARBAMAZEPINE EIA TEST
- K955138 — ANTI-EM/GP STOCKINGS
- K955292 — AELITEFLO
- K955383 — SPYROCOLLOID WOUND DRESSING
- K950473 — DISPOSABLE ECG MONITORING ELECTRODE
- K952780 — URINARY GEL DRAINAGE SYSTEM
- K953642 — AP-18
- K954319 — AMOXICILLIN/CLAVULANIC ACID 2/1
- K944612 — ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM
- K946249 — BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES
- K951028 — HAMEX TWO
- K951494 — AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)
- K951682 — OCTOSTIM
- K951898 — VERSA-VU
Data sourced from openFDA. This site is unofficial and independent of the FDA.