FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
125089–125112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 1990
ELECTROMEDICS BT422-120 AND BT422-40
K903392 · CAC
Electromedics, Inc.
Anesthesiology · 41d
Cleared Sep 06, 1990
SMALL JOINT INSTRUMENTS (SCISSOR HANDLE)
K903536 · LOS
Leonard Medical, Inc.
Cardiovascular · 30d
Cleared Sep 06, 1990
ARGENCO 9
K903548 · EJT
Argen Precious Metals, Inc.
Dental · 31d
Cleared Sep 06, 1990
ARGENCO 25
K903549 · EJT
Argen Precious Metals, Inc.
Dental · 30d
Cleared Sep 06, 1990
ARGIDENT 2A DENTAL GOLD ALLOY FOR PORECLAIN
K903677 · EJT
Argen Precious Metals, Inc.
Dental · 24d
Cleared Sep 06, 1990
DISPENSA-LUBE
K903717 · KMJ
Gam-Med Packaging Corp.
General Hospital · 23d
Cleared Sep 05, 1990
SPIRTOS COAXIAL CATHETER SET
K896524 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 294d
Cleared Sep 05, 1990
CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR
K896652 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 285d
Cleared Sep 05, 1990
(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000
K901253 · DTZ
Bio Medicus, Inc.
Cardiovascular · 173d
Cleared Sep 05, 1990
DUAL PORT
K901419 · LJT
Infusaid Corp.
General Hospital · 163d
Cleared Sep 05, 1990
VISION DIAGNOSTIC ULTRASONIC SCANNER
K901467 · IYO
The Probe Corp.
Radiology · 160d
Cleared Sep 05, 1990
AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT
K901641 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 149d
Cleared Sep 05, 1990
LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR)
K901835 · KNT
Lake Medical Products, Inc.
Gastroenterology & Urology · 139d
Cleared Sep 05, 1990
ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA
K901972 · LJC
Novo Nordisk Diagnostics, Ltd.
Microbiology · 127d
Cleared Sep 05, 1990
SELECTOR ULTRASONIC SURGICAL ASPIRATOR
K901974 · LFL
Spembly Medical , Ltd.
General & Plastic Surgery · 127d
Cleared Sep 05, 1990
MANAN BONE BIOPSY NEEDLE
K902177 · GDM
Manan Medical Products, Inc.
General & Plastic Surgery · 113d
Cleared Sep 05, 1990
PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
K902220 · DGR
Boehringer Mannheim Corp.
Immunology · 111d
Cleared Sep 05, 1990
SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER
K902349 · FZW
Surgitek
General & Plastic Surgery · 103d
Cleared Sep 05, 1990
THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK
K902546 · FXX
Anago, Inc.
General Hospital · 89d
Cleared Sep 05, 1990
THE PROTECTOR II, LASER SURGICAL MASK
K902547 · FXX
Anago, Inc.
General Hospital · 89d
Cleared Sep 05, 1990
MODIFICATION OF SEROCARD RUBELLA IGG TEST
K902571 · LFX
Disease Detection International, Inc.
Microbiology · 90d
Cleared Sep 05, 1990
PM GLOVES (MFG: BJL GLOVE (M) SDN.BHD.)
K902670 · LYY
Pm Gloves, Inc.
General Hospital · 79d
Cleared Sep 05, 1990
N-DEX
K902696 · LYY
Moss Point Glove Co.
General Hospital · 78d
Cleared Sep 05, 1990
SAFETY FIRST
K902708 · LYY
Bright Rubber Industries Private , Ltd.
General Hospital · 77d