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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
172201–172224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1978
KOVA TROL III
K780482 · JJW
Icl Scientific
Chemistry · 37d
Cleared May 03, 1978
CBR-T3 UPTAKE KIT
K780500 · KHQ
Clinical Bioresearch
Chemistry · 36d
Cleared May 03, 1978
CREATINE PHOSPHOKINASE (CPK)
K780504 · JHS
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared May 03, 1978
SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE
K780505 · CIT
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared May 03, 1978
CARBON DIOXIDE REAGENTS
K780506 · KMS
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared May 03, 1978
SERUM GLUTAMIC-PYRUVIC TRANSAMINASE
K780507 · CKC
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared May 03, 1978
QUANTITOPE 125I-FOLATE RADIOASSAY KIT
K780508 · CGN
Kallestad Laboratories, Inc.
Chemistry · 34d
Cleared May 03, 1978
AUTO/STAT KIT
K780512 · CGA
Pierce Chemical Co.
Chemistry · 34d
Cleared May 03, 1978
TRANSFER PIPET
K780592
Abco Dealers, Inc.
Chemistry · 23d
Cleared May 03, 1978
NDM INFANT ECG PACKPAD
K780631 · GYB
New Dimensions IN Medicine, Inc.
Neurology · 16d
Cleared May 03, 1978
EMIT CENTRIFICHEM THYROXINE ASSAY
K780639 · CDX
Syva Co.
Toxicology · 16d
Cleared May 03, 1978
LITECAST SOLDER
K780642 · EJH
Williams Gold Refining Co., Inc.
Dental · 16d
Cleared May 03, 1978
HMD-2000 BATTERY-POWERED MINI-DRILL, THE
K780645 · KIJ
Medishield, Inc.
Orthopedic · 16d
Cleared May 03, 1978
HEARING AID-MODEL 2010
K780667 · ESD
Radioear Corp.
Ear, Nose, Throat · 12d
Cleared May 03, 1978
HEATING AIDS-MODEL C78A & C78B
K780669 · ESD
Circle Hearing Instruments, Inc.
Ear, Nose, Throat · 12d
Cleared May 03, 1978
TISSUE PULSATOR
K780683 · ISA
Pulsator Corp.
Physical Medicine · 9d
Cleared May 03, 1978
GOAT ANTIINFLUENZA ANTISERA AUSSR
K780696 · GNS
Northeast Biomedical Labs., Inc.
Microbiology · 9d
Cleared May 03, 1978
GOAT ANTI-INFLUENZA ANTISERA ATEXAS
K780697 · GNS
Northeast Biomedical Labs., Inc.
Microbiology · 9d
Cleared May 03, 1978
EARETTE HEARING AID
K780699 · ESD
Opticon Corp.
Ear, Nose, Throat · 7d
Cleared Apr 28, 1978
AMINOGLYCOSIDE TEST SYSTEM
K772116 · DJB
Nichols Institute Diagnostics
Immunology · 172d
Cleared Apr 28, 1978
CLAMP, INCONTINENCE, BAUMRUCKER
K780137 · FHA
Greenwald Surgical Co., Inc.
Gastroenterology & Urology · 93d
Cleared Apr 28, 1978
ACCES. ANALOG OUTPUT ADAPTOR MODEL 910
K780358 · DXN
Applied Medical Research
Cardiovascular · 53d
Cleared Apr 28, 1978
RIA SYS. FOR HUMAN LUTEINIZING HORMONE
K780367 · CEP
Calbiochem-Behring Corp.
Microbiology · 52d
Cleared Apr 28, 1978
STAC SYSTEM
K780373 · CKA
Technicon Instruments Corp.
Chemistry · 51d