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
124153–124176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1990
ELECTRO-GONIOMETER DIAGNOSTIC DEVICE
K901290 · LBB
Chattanooga Group, Inc.
Neurology · 195d
Cleared Oct 01, 1990
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
K902084 · CBK
Ohmeda Medical
Anesthesiology · 146d
Cleared Oct 01, 1990
BAUER FLEXI-TEMNO BIOPSY NEEDLE
K902320 · FCG
Proact, Ltd.
Gastroenterology & Urology · 131d
Cleared Oct 01, 1990
RPI ENTERAL FEEDING BAG 1000ML AND 500ML
K902641 · KNT
Ridge Products, Inc.
Gastroenterology & Urology · 109d
Cleared Oct 01, 1990
DRIPTROL
K902808 · FLN
Trans-Pacific Healthcare-USA
General Hospital · 96d
Cleared Oct 01, 1990
SYNERMED CHOLESTEROL REAGENT KIT
K903015 · CHH
Synermed, Inc.
Chemistry · 83d
Cleared Oct 01, 1990
RACK-IT (R)
K903096 · FLE
Vengo Industries, Inc.
General Hospital · 80d
Cleared Oct 01, 1990
RESECTOSCOPE LOOPS
K903323 · KNS
Olympus Corp.
Gastroenterology & Urology · 68d
Cleared Oct 01, 1990
HICOR
K903375 · IZI
Siemens Gammasonics, Inc.
Radiology · 67d
Cleared Oct 01, 1990
CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR
K903403 · IWJ
University of Michigan
Radiology · 62d
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