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

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175,820 results
51697–51720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 2009
POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES
K092160 · LZA
Comfort Rubber Gloves Ind. Sdn. Bhd.
General Hospital · 134d
Cleared Nov 27, 2009
AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152
K092959 · FLL
Avita Corporation
General Hospital · 63d
Cleared Nov 27, 2009
CERNER CAREAWARE IBUS
K093134 · DRG
Cerner Corp.
Cardiovascular · 53d
Cleared Nov 27, 2009
1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD...
K093359 · DXN
Shanghai Little Doctor Co. Limited
Cardiovascular · 30d
Cleared Nov 27, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962,...
K093387 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d
Cleared Nov 25, 2009
RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
K090326 · HKI
Clarity Medical Systems
Ophthalmic · 289d
Cleared Nov 25, 2009
MULTI-BITE HOT BIOPSY FORCEPS
K090796 · KGE
Endo-Therapeutics, Inc.
Gastroenterology & Urology · 246d
Cleared Nov 25, 2009
EXILIS, MODEL 5000
K092191 · GEI
Btl Industries, Ltd.
General & Plastic Surgery · 127d
Cleared Nov 25, 2009
MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01
K092230 · LNH
Time Medical Limited
Radiology · 125d
Cleared Nov 25, 2009
EXPEDIUM SPINE SYSTEM
K092473 · NKB
Depuy Spine, Inc.
Orthopedic · 105d
Cleared Nov 25, 2009
MODIFICATION TO UNIGRAFT
K092567 · LYC
Unicare Biomedical, Inc.
Dental · 97d
Cleared Nov 25, 2009
VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS
K092693 · LSR
Viramed Biotech AG
Microbiology · 84d
Cleared Nov 25, 2009
PROPENCIL ESU PENCIL
K092732 · GEI
Bio Protech, Inc.
General & Plastic Surgery · 82d
Cleared Nov 25, 2009
3.0T 16 CHANNEL HEAD NECK SPINE COIL
K093348 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 29d
Cleared Nov 25, 2009
GDXPRO
K093521 · MYC
Carl Zeiss Meditec, Inc.
Ophthalmic · 12d
Cleared Nov 25, 2009
SVED WOUND TREATMENT SYSTEM
K093564 · OMP
Innovative Therapies, Inc.
General & Plastic Surgery · 7d
Cleared Nov 24, 2009
MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES
K083123 · GEX
Medart A/S
General & Plastic Surgery · 398d
Cleared Nov 24, 2009
INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
K090584 · JAD
Carl Zeiss Surgical GmbH
Radiology · 266d
Cleared Nov 24, 2009
ZIMMER MMC CUP
K091003 · KWA
Zimmer GmbH
Orthopedic · 230d
Cleared Nov 24, 2009
AXS-590 SERIES
K091650 · CAW
Swr International, Ltd.
Anesthesiology · 168d
Cleared Nov 24, 2009
POWDER FREE NITRILE EXAMINATION GLOVES BLACK
K091965 · LZA
Platinum Glove Industries Sdn. Bhd.
General Hospital · 146d
Cleared Nov 24, 2009
ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
K092104 · CGA
Arkray Factory USA, Inc.
Chemistry · 133d
Cleared Nov 24, 2009
GEBDI TRIBOS 501
K092231 · ELM
Gebdi Dental-Products GmbH
Dental · 124d
Cleared Nov 24, 2009
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
K092656 · KWP
Lanx, Inc.
Orthopedic · 88d