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
149977–150000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1985
MINI FLOW- DENTAL FLOSS
K844626 · JES
Mini Floss
Dental · 43d
Cleared Jan 09, 1985
SUNTAN CONNECTIONS BAHAMA SUN-BOOTH
K844870 · FTC
Suntan Connection
General & Plastic Surgery · 37d
Cleared Jan 08, 1985
LIGHT REFLECTION RHEOGRAPHY
K833561 · JOM
Instru-Med, Inc.
Cardiovascular · 454d
Cleared Jan 08, 1985
CELL-MATICS HERPES SIMPLEX VIRUS DETECT
K840366 · KIR
Difco Laboratories, Inc.
Microbiology · 347d
Cleared Jan 08, 1985
HEPARIN COATED ARTERIAL BLOOD FILTERS
K842813 · DTM
American Bentley
Cardiovascular · 174d
Cleared Jan 08, 1985
UROCYSTIN
K843382 · JLC
Mission Pharmacal Co.
Chemistry · 133d
Cleared Jan 08, 1985
PERMATHANE 865 & 867 UNIPOLAR POLYURETH
K843703 · DTD
Pacesetter Systems
Cardiovascular · 109d
Cleared Jan 08, 1985
MEDTRONIC 6957J
K843707 · DTB
Medtronic Vascular
Cardiovascular · 109d
Cleared Jan 08, 1985
SCIMED II MEMBRANE OXYGENATOR SYSTEM
K843956 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 91d
Cleared Jan 08, 1985
LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN
K844125 · JJY
Bio-Rad
Chemistry · 77d
Cleared Jan 08, 1985
ALT/GPT REAGENT SET
K844251 · CKA
Sterling Biochemical, Inc.
Chemistry · 67d
Cleared Jan 08, 1985
DATA-CHEM MAGNESIUM
K844278 · JGJ
Data Medical Associates, Inc.
Chemistry · 64d
Cleared Jan 08, 1985
TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE
K844343 · FIE
Top Surgical Manufacturers Co.
Gastroenterology & Urology · 60d
Cleared Jan 08, 1985
RESPIRALEX LATEX AGGLUTINATION TEST
K844399 · GTZ
Orion Diagnostica, Inc.
Immunology · 56d
Cleared Jan 08, 1985
DERMIDRESS
K844463 · KGX
Kells Medical, Inc.
General & Plastic Surgery · 49d
Cleared Jan 08, 1985
BARD URETEROSCOPIC CYTOLOGY BRUSH
K844561 · FDX
C.R. Bard, Inc.
Gastroenterology & Urology · 48d
Cleared Jan 08, 1985
ELECTROCAINE MODEL SR-IV
K844638 · GZJ
Electrocaine Medical System
Neurology · 41d
Cleared Jan 08, 1985
COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM
K844684 · KNX
Coloplast A/S
Gastroenterology & Urology · 39d
Cleared Jan 08, 1985
COLOPLAST URO 2002 UROSTOMY SYSTEM
K844685 · EXB
Coloplast A/S
Gastroenterology & Urology · 39d
Cleared Jan 08, 1985
CRITIC-ARS
K844709 · JIX
Dimension Diagnostics
Chemistry · 36d
Cleared Jan 08, 1985
INNOFLUOR PRIMIDONE
K844721 · LKT
Innotron Diagnostics
Toxicology · 35d
Cleared Jan 08, 1985
FOCUS UREA NITROGEN
K844755 · CDQ
Abbott Laboratories
Chemistry · 33d
Cleared Jan 08, 1985
UROL-QUAL
K844760 · JJY
Dimension Diagnostics
Chemistry · 32d
Cleared Jan 08, 1985
EFF-EFFNER BULBS
K844773 · FFS
Mecron Medical Products, Inc.
Gastroenterology & Urology · 29d