FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
171361–171384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 28, 1978
BIOPHYSICAL MONITORING SYSTEM
K780425 · DXJ
Gould, Inc.
Cardiovascular · 42d
Cleared Apr 28, 1978
FIBER OPTIC HANDPIECE
K780483 · EFB
Syntex Corp.
Dental · 32d
Cleared Apr 28, 1978
STIKSEP-T3 KIT
K780486 · CEE
Nuclear Diagnostics, Inc.
Chemistry · 32d
Cleared Apr 28, 1978
GAMMA STIK 125I T3 UPTAKE KIT
K780492 · CDP
Alpha Gamma Laboratory
Chemistry · 32d
Cleared Apr 28, 1978
GENTAMICIN RIA KIT
K780516 · DJB
Antibodies, Inc.
Immunology · 29d
Cleared Apr 28, 1978
ULTRANOVAR, DENTAL U.V. CURING LAMP
K780518 · EBZ
Demetron Research Corp.
Dental · 28d