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
152329–152352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 1984
REUSEABLE NON-CONDUCTIVE FIXED Y
K841455 · CAI
Dryden Corp.
Anesthesiology · 63d
Cleared Jun 11, 1984
PRESSURE CATHETER PLACEMENT SET 50010
K841482 · DWF
Dlp, Inc.
Cardiovascular · 63d
Cleared Jun 11, 1984
MODEL 1000 APC-ANGIOPLASTY PRESSURE
K841493 · DXT
E.A. Fischione Instrument Mfg.
Cardiovascular · 62d
Cleared Jun 11, 1984
QUICK-COUNT PLUS 2
K841504 · GKL
Seragen Diagnostics, Inc.
Hematology · 62d
Cleared Jun 11, 1984
IMPACT MODEL 308
K841538 · JCX
Impact Instrumentation, Inc.
General & Plastic Surgery · 56d
Cleared Jun 11, 1984
STERILE BLOOD LANCETS
K841677 · FMK
Abco Dealers, Inc.
General & Plastic Surgery · 49d
Cleared Jun 11, 1984
HOLDER FOR BOS-10, 10S 5S
K841812 · KRI
American Bentley
Cardiovascular · 41d
Cleared Jun 11, 1984
MODIFICATION TO ACS CORONARY GUIDING
K841992 · DAO
Advanced Cardiovascular Systems, Inc.
Immunology · 47d
Cleared Jun 11, 1984
AUTOMATED EIA MICROPLATE READER EL310
K842085 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 18d
Cleared Jun 11, 1984
SPUNGARD & SURG. DRAPES-GOWNS & PACKS
K842115 · KKX
Kimberly-Clark Corp.
General Hospital · 47d
Cleared Jun 08, 1984
BIOPSY PUNCH, VARIOUS
K841008 · GEE
Premier Dental Products Co.
General & Plastic Surgery · 91d
Cleared Jun 08, 1984
ENZYMATIC CO2 DIAGNOSTIC CHEMICAL
K841664 · KHS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Jun 08, 1984
TDX REA LDH
K841703 · CFJ
Abbott Laboratories
Chemistry · 46d
Cleared Jun 08, 1984
ZERO-G
K842120 · KIC
Steridyne Corp.
Physical Medicine · 10d
Cleared Jun 07, 1984
NITROUS OXIDE RECYCLER
K834535 · BSF
G & L Unltd.
Anesthesiology · 168d
Cleared Jun 07, 1984
GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB
K840326 · CAM
Siemens Elema AB
Anesthesiology · 134d
Cleared Jun 07, 1984
KIDNEY TRANSPLANT CATHETER
K840687 · KDN
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 113d
Cleared Jun 07, 1984
CONTACT LENS CASE FOR SOFT LENSES
K840692 · LRX
Optimum Manufacturers, Inc.
Ophthalmic · 112d
Cleared Jun 07, 1984
ENTEROSCOPE
K840722 · FDA
Trimedyne, Inc.
Gastroenterology & Urology · 111d
Cleared Jun 07, 1984
TRANSPORTER VIRAL TRANSPORT MEDIUM
K840744 · KIT
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 105d
Cleared Jun 07, 1984
V.D.T.-GONORRHEA TEST KIT
K840799 · LIO
M.G. Laboratories, Inc.
Microbiology · 105d
Cleared Jun 07, 1984
ANTIMICROBIAL INCISE DRAPE
K840957 · KKX
American Convertors Div., American...
General Hospital · 93d
Cleared Jun 07, 1984
HALOTHANE VAPORIZER 950, ENFLURANE
K841157 · CAD
Siemens Elema AB
Anesthesiology · 80d
Cleared Jun 07, 1984
RUBELLA ANTIBODY FLUOROIMMUNOASSAY
K841174 · GOL
Intl. Diagnostic Technology
Microbiology · 80d