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
124753–124776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1990
COMFIT SURGEON'S GLOVES
K903446 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 66d
Cleared Oct 01, 1990
PREMIER-C. DIFFICILE TOXIN A
K903456 · LLH
Meridian Diagnostics, Inc.
Toxicology · 61d
Cleared Oct 01, 1990
MODEL 4500-SMS-42
K903822 · LNH
Medical Advances, Inc.
Radiology · 42d
Cleared Oct 01, 1990
TRIGLYCERIDES REAGENT GPO 5 X CONC.
K903897 · CDT
Trace Scientific , Ltd.
Chemistry · 39d
Cleared Oct 01, 1990
SPIVE NEEDLE SYSTEM, MODIFICATION
K904013 · FPA
Pascall Medical Corp.
General Hospital · 33d
Cleared Oct 01, 1990
MULTI DRUG INFUSION SYSTEM
K904048 · FRN
I-Flow Corp.
General Hospital · 27d
Cleared Oct 01, 1990
SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED
K904286 · FRW
Scale-Tronix, Inc.
General Hospital · 33d
Cleared Oct 01, 1990
RHEUMAGEN CRP T-CONTROL
K904312 · DCK
Biokit USA, Inc.
Immunology · 12d
Cleared Sep 28, 1990
GAMBRO BICARBONATE MONITOR BCM 10-3
K896758 · FKP
Gambro, Inc.
Gastroenterology & Urology · 301d
Cleared Sep 28, 1990
PARKER AMBULATORY MEDICATION INFUSION PUMP 2004
K897086 · FRN
Parker Hannifin Corp.
General Hospital · 282d
Cleared Sep 28, 1990
STERIMATIC(TM) SAFETY NEEDLE
K901162 · FMI
Sterimatic Worldwide, Ltd.
General Hospital · 199d
Cleared Sep 28, 1990
RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS
K901289 · LXH
Mumtaz I. Malik
Physical Medicine · 192d
Cleared Sep 28, 1990
VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8
K901420 · LXH
Mumtaz I. Malik
Orthopedic · 186d
Cleared Sep 28, 1990
CHISEL, BONE, SURGICAL
K901511 · LXH
Mumtaz I. Malik
Physical Medicine · 183d
Cleared Sep 28, 1990
OSTEOTOMES OF VARIOUS TYPES
K901521 · LXH
Mumtaz I. Malik
Physical Medicine · 179d
Cleared Sep 28, 1990
MULTI-DRUG INFUSION SYSTEM
K901978 · FRN
I-Flow Corp.
General Hospital · 149d
Cleared Sep 28, 1990
O. B. PACK IV
K902032 · HFC
Customed, Inc.
Obstetrics & Gynecology · 147d
Cleared Sep 28, 1990
SURGICAL TOWEL
K902715 · KKX
Aztec Medical, Inc.
General Hospital · 100d
Cleared Sep 28, 1990
SOFTOUCH GUIDING CATHETER
K902953 · DQO
Mallinckrodt Medical
Cardiovascular · 85d
Cleared Sep 28, 1990
BEAMER 1,2,4,6, AND 8
K903724 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 43d
Cleared Sep 27, 1990
PARTNER VOLUME MONITOR
K901885 · BZK
Bird Products Corp.
Anesthesiology · 154d
Cleared Sep 27, 1990
ROADRUNNER WIRE GUIDE
K901899 · DQX
Cook, Inc.
Cardiovascular · 153d
Cleared Sep 27, 1990
RESUBMITTED MULTIORGAN PERFUSION CANNULA
K902394 · DWF
Fresenius USA, Inc.
Cardiovascular · 120d
Cleared Sep 27, 1990
MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE
K902429 · LDD
Laerdal Mfg. Corp.
Cardiovascular · 128d