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
169657–169680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1979
FILTERSET 0.22, I.V. PUMP
K790108 · FPA
Imed Corp.
General Hospital · 49d
Cleared Mar 06, 1979
INFANT CARE SYSTEM
K790137 · FMT
Narco Air-Shields
General Hospital · 43d
Cleared Mar 06, 1979
MONITOR PLUG-IN MODEL M1106 ECG
K790198 · DRT
Electronics For Medicine, Inc.
Cardiovascular · 40d
Cleared Mar 06, 1979
TRAY AND BAG, CATHETERIZATION
K790271 · FCM
Snyder Laboratories, Inc.
Gastroenterology & Urology · 56d
Cleared Mar 06, 1979
TRAY, URETHRAL CATHETERIZATION
K790272 · FCM
Snyder Laboratories, Inc.
Gastroenterology & Urology · 52d
Cleared Mar 06, 1979
CATHETER, MMG LATEX EXTERNAL
K790279 · KNX
Medical Marketing Group
Gastroenterology & Urology · 21d
Cleared Mar 06, 1979
FLUID ADMINISTRATION SETS, 15 MICRON
K790314 · FPB
Medex, Inc.
General Hospital · 21d
Cleared Mar 06, 1979
ANAMETRIC TIBIAL COMPONENT METAL TRAY
K790348 · HRY
Howmedica Corp.
Orthopedic · 13d
Cleared Mar 06, 1979
TOTAL CONDYLAR KNEE PROSTHESIS
K790349 · HRY
Howmedica Corp.
Orthopedic · 13d
Cleared Mar 06, 1979
POSTERIOR CRUCIATE CONDYLAR TIBIAL
K790350 · HRY
Howmedica Corp.
Orthopedic · 13d
Cleared Mar 06, 1979
MODEL 342 HEARING AIDS
K790354 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 12d
Cleared Mar 06, 1979
MODEL 342D HEARING AIDS
K790355 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 12d
Cleared Mar 02, 1979
RIA KIT, PROGESTERONE
K782009 · JLS
The Upjohn Co.
Chemistry · 91d
Cleared Mar 02, 1979
UNITEST AMYLASE
K782032 · CIW
Boehringer Mannheim Corp.
Chemistry · 86d
Cleared Mar 02, 1979
THERA CHEM
K782128 · DIF
Fisher Scientific Co., LLC
Toxicology · 65d
Cleared Mar 02, 1979
UNITEST CREATINE KINASE
K782156 · JLB
Boehringer Mannheim Corp.
Chemistry · 70d
Cleared Mar 02, 1979
STIMULATOR, MENTOR 100 NERVE
K790011 · GZJ
Mentor Corp.
Neurology · 59d
Cleared Mar 02, 1979
DIGITAL BPM
K790036 · DXO
Narco Air-Shields
Cardiovascular · 53d
Cleared Mar 02, 1979
SPINSEP-FE59
K790133 · JQG
Nuclear Diagnostics, Inc.
Immunology · 38d
Cleared Mar 02, 1979
INTERVAL TIMER MODEL V4295
K790203 · DRR
Electronics For Medicine, Inc.
Cardiovascular · 31d
Cleared Mar 02, 1979
SARNS WIRE-REINFORCED VENOUS RETURN CAN
K790246 · DWF
3M Health Care, Sarns
Cardiovascular · 24d
Cleared Mar 02, 1979
EMIT AED ASSAYS 3500 COMPUTER DIRECTED
K790255 · KLT
Syva Co.
Toxicology · 24d
Cleared Mar 02, 1979
EMIT THEOPHYLLINE ASSAY
K790256 · KLS
Syva Co.
Toxicology · 24d
Cleared Mar 02, 1979
REPRODENT
K790325 · EBI
Premier Dental Products Co.
Dental · 15d