Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
42721–42744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2012
AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX...
K120326 · JHX
Radiometer Medical Aps
Chemistry · 293d
Cleared Nov 21, 2012
STR GRAFT
K121216 · OWW
Soft Tissue Regeneration, Inc.
Orthopedic · 212d
Cleared Nov 21, 2012
VECTTOR VT-200
K121662 · LIH
Alan Neuromedical Technologies, LLC
Neurology · 169d
Cleared Nov 21, 2012
POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
K121811 · LZC
Shen Wei (Usa), Inc.
General Hospital · 154d
Cleared Nov 21, 2012
HEMASORB APPLY
K121953 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 141d
Cleared Nov 21, 2012
PLANMED NUANCE DIGIGUIDE
K121963 · MUE
Planmed OY
Radiology · 139d
Cleared Nov 21, 2012
ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
K122110 · CGA
ACON Laboratories, Inc.
Chemistry · 127d
Cleared Nov 21, 2012
POWERPLAY MUSCLE MASSAGER
K122154 · IRP
Fig, LLC
Physical Medicine · 124d
Cleared Nov 21, 2012
CORIN TRINITY-I ACETABULAR SHELL
K122305 · LZO
Corin USA
Orthopedic · 112d
Cleared Nov 21, 2012
MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
K122581 · DQY
Concentric Medical, Inc.
Cardiovascular · 90d
Cleared Nov 21, 2012
.DECIMAL PHOTON BLOCK
K123015 · IXI
.Decimal, Inc.
Radiology · 54d
Cleared Nov 20, 2012
RUMBLE TUFF
K113315 · HGX
Acute Ideas Co. , Ltd.
Obstetrics & Gynecology · 377d
Cleared Nov 20, 2012
HET BIPOLAR LIGATOR SYSTEM
K121085 · GEI
Het Systems, LLC
General & Plastic Surgery · 224d
Cleared Nov 20, 2012
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
K121220 · KWS
Exactech, Inc.
Orthopedic · 211d
Cleared Nov 20, 2012
GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
K121234 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 210d
Cleared Nov 20, 2012
THERMOFORMED MOUTHGUARDS
K121365 · MQC
Glidewell Laboratories-Sleep Devices...
Dental · 197d
Cleared Nov 20, 2012
FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
K121499 · IZF
Fujifilm Medical System U.S.A., Inc.
Radiology · 183d
Cleared Nov 20, 2012
VITEK 2 GRAM NEGATIVE DOXYCYCLINE
K121546 · LON
bioMerieux, Inc.
Microbiology · 179d
Cleared Nov 20, 2012
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
K121603 · JJY
Randox Laboratories, Ltd.
Chemistry · 228d
Cleared Nov 20, 2012
AIRSTRIP RPM FOR LIFENET CONSULT
K121712 · MSX
Airstrip Technologies, Inc.
Cardiovascular · 162d
Cleared Nov 20, 2012
HEALTHMATEFOREVER
K121757 · NUH
Healthmate International, LLC
Neurology · 158d
Cleared Nov 20, 2012
CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE
K121846 · BSP
B.Braun Medical, Inc.
Anesthesiology · 148d
Cleared Nov 20, 2012
ZOLL RESCUENET 12-LEAD
K121865 · MSX
ZOLL Medical Corporation
Cardiovascular · 147d
Cleared Nov 20, 2012
PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
K121977 · GEI
Plasma Surgical Limited
General & Plastic Surgery · 138d