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
140161–140184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1987
THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
K870514 · BWF
Health Products, Inc.
Anesthesiology · 54d
Cleared Mar 31, 1987
SYSTEM 9000 AUTOMATED CELL COUNTER
K870603 · GKL
Baker Instructions Corp.
Hematology · 48d
Cleared Mar 31, 1987
O.O2 M CALCIUM CHLORIDE SOLUTION
K870688 · JPA
U. S. Diagnostics, Inc.
Hematology · 40d
Cleared Mar 31, 1987
MCGHAN TISSUE EXPANDER FILL SYSTEM
K870754 · LCJ
Mcghan Medical Corp.
General & Plastic Surgery · 33d
Cleared Mar 31, 1987
ABBOTT SPECTRUM AMMONIA REAGENT
K870787 · JIF
Abbott Laboratories
Chemistry · 33d
Cleared Mar 31, 1987
T7202 THIO W/O IND W/DEXTROSE
K870798 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 32d
Cleared Mar 31, 1987
T2500 FLUID THIO
K870799 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 32d
Cleared Mar 31, 1987
T2570 THIO W/O IND W/O DEXTROSE
K870800 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 32d
Cleared Mar 31, 1987
NBF 10% NEUTRAL BUFFERED FORMALIN
K870852 · IFP
Anatech, Ltd.
Pathology · 28d
Cleared Mar 31, 1987
HL-1 SUPPLEMENT
K870876 · KIT
Ventrex Laboratories, Inc.
Hematology · 28d
Cleared Mar 31, 1987
WARD'S BREAST MEASURING DEVICE
K870887
Downs Surgical , Ltd.
General & Plastic Surgery · 26d
Cleared Mar 31, 1987
THE GRIPPER SEAL(TM)
K870900 · KGX
Pharmacia Deltec, Inc.
General & Plastic Surgery · 26d
Cleared Mar 31, 1987
SURGIFRESH SURGICAL SMOKE REMOVAL
K870932
Texas Medical Products, Inc.
General & Plastic Surgery · 22d
Cleared Mar 31, 1987
FETAL BOVINE SERUM
K870938 · KIS
Hyclone Laboratories, Inc.
Pathology · 22d
Cleared Mar 31, 1987
THEOPHYLLINE FPIA REAGENT SET
K870952 · KLS
Sigma Diagnostics, Inc.
Toxicology · 21d
Cleared Mar 31, 1987
PHENYTOIN FPIA REAGENT SET
K870953 · DIP
Sigma Diagnostics, Inc.
Toxicology · 21d
Cleared Mar 31, 1987
2, 3 AND 4 BANDAGE COMPRESS
K870993 · EFQ
Advantage Credit Services, Inc.
General & Plastic Surgery · 20d
Cleared Mar 31, 1987
1X5YD,2X6YD,3X5YD,4X6YD,1/2/3X10YD GAUZE
K871002 · EFQ
Advantage Credit Services, Inc.
General & Plastic Surgery · 20d
Cleared Mar 31, 1987
18X36,36X36,18X72,24X72 GAUZE COMPRESS
K871005 · EFQ
Advantage Credit Services, Inc.
General & Plastic Surgery · 18d
Cleared Mar 31, 1987
RABBIT KIDNEY CULTURE CELLS (FIRST PASS)
K871033 · KIR
Microscan Div. Baxter Healthcare Corp.
Pathology · 15d
Cleared Mar 31, 1987
RF MICROASSAY
K871041 · DHR
Diamedix Corp.
Microbiology · 14d
Cleared Mar 31, 1987
MEDICAM S-4 SURGICAL CAMERA
K871056 · FWF
M.P. Video, Inc.
General & Plastic Surgery · 14d
Cleared Mar 31, 1987
CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D
K871119 · JAA
Canon USA, Inc.
Radiology · 12d
Cleared Mar 31, 1987
EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR
K871145 · IZO
Electromed Intl., Ltd.
Radiology · 8d