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
153217–153240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1984
TRIGLYCERIDES REAGENT
K840780 · CDT
American Dade
Chemistry · 57d
Cleared Apr 05, 1984
PARAMAX UREA NITROGEN REAGENT
K840785 · CDQ
American Dade
Chemistry · 50d
Cleared Apr 05, 1984
BITESTICK BLOCK
K840789 · JXL
Cherry Plastics, Inc.
Neurology · 62d
Cleared Apr 05, 1984
TRNS MI 8202
K840821 · GZJ
Medical Scientific Instruments
Neurology · 41d
Cleared Apr 05, 1984
LEAP MONO TEST KIT
K840822 · KTN
Cooper Biomedical, Inc.
Immunology · 41d
Cleared Apr 05, 1984
THERACHEM TDC THERAPEUTIC DRUG CONTROL
K840921 · DIF
Fisher Diagnostics
Toxicology · 34d
Cleared Apr 05, 1984
MANUAL RESUSCITATION SYSTEM
K840935 · BTM
Inspiron Corp.
Anesthesiology · 31d
Cleared Apr 05, 1984
SOMAS HUMAN SPINAL FLUID CONTROL
K840974 · DFI
Somas Medical Industries, Inc.
Immunology · 30d
Cleared Apr 05, 1984
PREFILLED PULSATOR SYRINGE
K840986 · CBT
Concord Laboratories, Inc.
Anesthesiology · 29d
Cleared Apr 05, 1984
VAPORIZED HEPARIN
K840987 · CBT
Concord Laboratories, Inc.
Anesthesiology · 29d
Cleared Apr 05, 1984
PANCRETEC PUMP CHECK
K841018 · FRN
Pancretec, Inc.
General Hospital · 27d
Cleared Apr 05, 1984
PROVIDER CAP SET
K841028 · FPA
Pancretec, Inc.
General Hospital · 24d
Cleared Apr 05, 1984
RES-Q-MATE
K841120 · CAE
Rsq Industries, Inc.
Anesthesiology · 21d
Cleared Apr 05, 1984
LEVINE EOSIN METHYLENE BLUE AGAR
K841142 · JSI
Anaerobe Systems
Microbiology · 20d
Cleared Apr 05, 1984
PROPAGATING TRANSPORT
K841208 · JSN
Smith River Biologicals
Microbiology · 24d
Cleared Apr 05, 1984
SELECTIVE BROTH
K841211 · JSD
Smith River Biologicals
Microbiology · 24d
Cleared Apr 05, 1984
CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR
K841218 · JSI
Anaerobe Systems
Microbiology · 14d
Cleared Apr 05, 1984
FILTER-FLEX
K841236 · CAH
Life Design Systems, Inc.
General Hospital · 14d
Cleared Apr 05, 1984
DISPOSABLE ANESTHESIA MASK
K841240 · BSJ
Hospitak, Inc.
Anesthesiology · 13d
Cleared Apr 04, 1984
SDI SURGICAL DRAPE
K833176 · KKX
Sdi
General Hospital · 198d
Cleared Apr 04, 1984
ADRENOCORTICOTROPIC HORMONE TEST
K833934 · CKG
Clinetics Corp.
Chemistry · 142d
Cleared Apr 04, 1984
EPILOT 80 S TM
K833946 · KCW
Leo Unlimited, Inc.
General & Plastic Surgery · 141d
Cleared Apr 04, 1984
BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO
K834048 · GEI
Castle Co.
General & Plastic Surgery · 133d
Cleared Apr 04, 1984
OP-CON SURG. INSTRUMENT #3
K834171 · KOA
Imm Enterprises , Ltd.
Gastroenterology & Urology · 135d