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
151729–151752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1984
TUBULAR HOLLOW FIBER MEMBRANE
K841476 · DTZ
American Bentley
Cardiovascular · 116d
Cleared Aug 03, 1984
SCANLAN ENDARSECTOR
K841521 · DWX
Scanlan Intl., Inc.
Cardiovascular · 113d
Cleared Aug 03, 1984
LEPTOS
K841635 · DXY
Biotronik Sales, Inc.
Cardiovascular · 106d
Cleared Aug 03, 1984
MODEL 866 PERMATHANE BIPOLAR, COAXIAL
K841739 · DTD
Pacesetter Systems
Cardiovascular · 98d
Cleared Aug 03, 1984
FASTPASS IMPLANTABLE ENDOCARDIAL PAC
K841885 · DTD
Pacesetter Systems
Cardiovascular · 88d
Cleared Aug 03, 1984
CARDIOPLEGIA RESERVOIR CAS-2000
K841938 · DTN
American Bentley
Cardiovascular · 84d
Cleared Aug 03, 1984
VAN-TEC URETERAL DILATION BALLOON CATH
K841940 · EZN
Van-Tec, Inc.
Gastroenterology & Urology · 84d
Cleared Aug 03, 1984
MODEL 110-5 & 140-8
K842005 · DXO
Camino Laboratories, Inc.
Cardiovascular · 78d
Cleared Aug 03, 1984
CENTRIMED SYSTEM 1
K842007 · KFM
Centrimed Corp.
Cardiovascular · 78d
Cleared Aug 03, 1984
IMPACT MODEL 316
K842050 · JCX
Impact Instrumentation, Inc.
General & Plastic Surgery · 73d
Cleared Aug 03, 1984
COBE EMERGENCY POWER SOURCE 43610-000
K842138 · DTQ
Cobe Laboratories, Inc.
Cardiovascular · 65d
Cleared Aug 03, 1984
SOLUTION CLARIFICATION UNIT
K842141 · KRJ
Pall Biomedical Products Co.
Cardiovascular · 65d
Cleared Aug 03, 1984
AIR SHIELDS AS461 MONITORING SYS
K842321 · DRT
Air-Shields, Inc.
Cardiovascular · 52d
Cleared Aug 03, 1984
AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN
K842328 · DEH
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 51d
Cleared Aug 03, 1984
CAVI-MED
K842581 · ELC
Cooper Lasersonics, Inc.
Dental · 31d
Cleared Aug 03, 1984
IMMUSTAPH LATEX AGGLUTINATION KIT
K842709 · LHJ
Immucell Corp.
Microbiology · 22d
Cleared Aug 03, 1984
LIMONENE
K842721 · KEM
E K Ind., Inc.
Pathology · 21d
Cleared Aug 03, 1984
SALINE, 1.3% W/O PRESERVATIVE
K842723 · KIP
E K Ind., Inc.
Pathology · 21d
Cleared Aug 03, 1984
SALINE 0.85% W/O PRESERVATIVE
K842724 · KIP
E K Ind., Inc.
Pathology · 21d
Cleared Aug 03, 1984
SALINE, 0.85%W/PRESERVATIVE
K842725 · KIP
E K Ind., Inc.
Hematology · 21d
Cleared Aug 03, 1984
DECALCIFIER SOLUTION
K842726 · KDX
E K Ind., Inc.
Pathology · 21d
Cleared Aug 03, 1984
SUPERMOUNT
K842727 · LED
E K Ind., Inc.
Pathology · 21d
Cleared Aug 03, 1984
BUF-FIX
K842728 · IFP
E K Ind., Inc.
Pathology · 21d
Cleared Aug 03, 1984
DECOLORIZING FLUID
K842729 · PPM
E K Ind., Inc.
Hematology · 21d