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
162673–162696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1981
NEPHELOMETRIC SOLID TURBIDITY STANDARD
K812220 · JIW
Hyland Therapeutic Div., Travenol...
Immunology · 12d
Cleared Aug 17, 1981
UVA SUN TANNING EQUIPMENT
K811870 · FTC
Cpc Systems, Inc.
Radiology · 47d
Cleared Aug 13, 1981
ESOPHAGEAL MOTILITY PROBE
K811083 · FFT
Konigsberg Instruments, Inc.
Gastroenterology & Urology · 114d
Cleared Aug 13, 1981
GLUCOSE OXIDASE RATE REAGENT
K811165 · CGA
Chem-Elec, Inc.
Chemistry · 107d
Cleared Aug 13, 1981
PACEPATH IMPLANTABLE ENDOCARD. PACING LD
K811200 · DTB
Pacesetter Systems
Cardiovascular · 105d
Cleared Aug 13, 1981
CHLORIDE REAGENT KIT
K811319 · JFS
Chem-Elec, Inc.
Chemistry · 93d
Cleared Aug 13, 1981
ULTRASONIC QFM SYSTEM 1000
K811376 · DPW
Narco Bio-Systems
Cardiovascular · 90d
Cleared Aug 13, 1981
ASTRA
K811381 · JFL
Chem-Elec, Inc.
Chemistry · 90d
Cleared Aug 13, 1981
CREATININE RATE REAGENT KIT
K811406 · CGX
Chem-Elec, Inc.
Chemistry · 86d
Cleared Aug 13, 1981
MODIFIED THORACENTESIS CATHETER
K811437 · KDQ
Blair Medical Products
General Hospital · 83d
Cleared Aug 13, 1981
MICRO-AIRE REPLACEMENT SAW BLADES
K811506 · GFA
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 78d
Cleared Aug 13, 1981
SPACELABS' SYSTEM AUTORECORDER
K811540 · DSF
Spacelabs, Inc.
Cardiovascular · 73d
Cleared Aug 13, 1981
ARRHYTHMIA FUNCTION BLOCK
K811581 · DSI
Honeywell, Inc.
Cardiovascular · 69d
Cleared Aug 13, 1981
F72T12/BL-S/HO UVA SUNLAMP
K811585 · FTC
Westinghouse Electric Corp.
Radiology · 69d
Cleared Aug 13, 1981
F72T12/BL-S/SHO-O UVA SUNLAMP
K811586 · FTC
Westinghouse Electric Corp.
Radiology · 69d
Cleared Aug 13, 1981
BACH-SIMPSON MODEL BVM30
K811615 · DPW
Bach-Simpson , Ltd.
Radiology · 66d
Cleared Aug 13, 1981
BACH-SIMPSON MODEL TS266
K811616 · DPW
Bach-Simpson , Ltd.
Radiology · 66d
Cleared Aug 13, 1981
RUBELLA LATEX CARD TEST
K811637 · DOK
Bd Becton Dickinson Vacutainer...
Microbiology · 64d
Cleared Aug 13, 1981
HEMOTHERM MODEL 400
K811742 · DWJ
Cincinnati Sub-Zero
Cardiovascular · 55d
Cleared Aug 13, 1981
NEIA PAP ENZYMEIMMUNOASSAY
K811757 · JFH
New England Immunology Assoc.
Immunology · 52d
Cleared Aug 13, 1981
SENSITITIRE AP60
K811765 · JSS
Gibco Laboratories Life Technologies,...
Microbiology · 52d
Cleared Aug 13, 1981
ADAPTAID LEAD ADAPTER, #365-17
K811920 · DTD
Intermedics, Inc.
Cardiovascular · 42d
Cleared Aug 13, 1981
DSS 500
K811934 · KPR
Philips Medical Systems (Cleveland),...
Radiology · 38d
Cleared Aug 13, 1981
KENL-ECG-3
K811949 · DPS
Suzuken Co., Ltd.
Cardiovascular · 37d