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
124321–124344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1990
IL GENTAMICIN ASSAY SYSTEM
K903743 · LCD
Instrumentation Laboratory CO
Toxicology · 32d
Cleared Sep 17, 1990
SERIES 9000 LIFT-RECLINE CHAIR
K903905 · INO
Equi-Tron Mfg., Inc.
Physical Medicine · 25d
Cleared Sep 17, 1990
BIOTRACK THEOPHYLLINE QUALITY CONTROLS
K903924 · LAW
Biotrack, Inc.
Toxicology · 24d
Cleared Sep 17, 1990
KODAK SURECELL HERPES (HSV) CONTROL FLUID SET
K903926 · LGC
Eastman Kodak Company
Microbiology · 27d
Cleared Sep 17, 1990
WHEELCHAIRS, TRANSIT/FOLDING/GLIDEABOUT/ACCESS
K903981 · IOR
D.M.A. , Ltd.
Physical Medicine · 28d
Cleared Sep 17, 1990
BRODA NURSING CARE CHAIR
K904069 · INN
Broda Ent., Inc.
Physical Medicine · 13d
Cleared Sep 14, 1990
9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON
K892222 · DSP
Kontron Instruments, Inc.
Cardiovascular · 529d
Cleared Sep 14, 1990
CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO
K894959 · JEC
Alphatec Mfg., Inc.
Orthopedic · 403d
Cleared Sep 14, 1990
ACSYS PREFIX ACETABULAR CUP PROSTHESIS
K900261 · JDI
3M Company
Orthopedic · 240d
Cleared Sep 14, 1990
ACSYS SELFTAP ACETABULAR CUP PROSTHESIS
K900262 · LWJ
3M Company
Orthopedic · 240d
Cleared Sep 14, 1990
CRI CYNOSAR CATHETER
K900320 · DRA
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 234d
Cleared Sep 14, 1990
ACSYS SHEARER ACETABULAR CUP PROSTHESIS
K900435 · LWJ
3M Company
Orthopedic · 227d
Cleared Sep 14, 1990
ROTABLATOR
K901206 · MCW
Heart Technology, Inc.
Cardiovascular · 184d
Cleared Sep 14, 1990
VINYL SILICONE ELASTOMER MATERIAL
K901990 · MDA
Crown Delta Corp.
General & Plastic Surgery · 135d
Cleared Sep 14, 1990
SILICONE ELASTOMER PUTTY
K901991 · MDA
Crown Delta Corp.
General & Plastic Surgery · 135d
Cleared Sep 14, 1990
K-CAP-I ORTHOPEDIC FIXATION WIRE CAP
K902053 · LYT
Westcon Orthopedics, Inc.
Orthopedic · 130d
Cleared Sep 14, 1990
CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM
K902374 · FRN
Pharmacia Deltec, Inc.
General Hospital · 107d
Cleared Sep 14, 1990
MICROGUARD, ORTHOPEDIC PIN PROTECTORS
K902676 · LYT
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 87d
Cleared Sep 14, 1990
BIOSEARCH ANAL BIOFEEDBACK DEVICE
K902843 · FAP
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 78d
Cleared Sep 14, 1990
BIOSITE DIAGNOSTICS OPIATE SCREENING TEST
K902924 · DJG
Biosite Incorporated
Toxicology · 74d
Cleared Sep 14, 1990
NEOS (TM) 02 B PULSE GENERATOR
K903081 · DXY
Biotronik, GmbH & Co.
Cardiovascular · 64d
Cleared Sep 14, 1990
RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT
K903123 · JIQ
Reagents Applications, Inc.
Chemistry · 60d
Cleared Sep 14, 1990
SELECT 20, DENTAL ALLOY
K903484 · EJT
Leach and Dillon Co., Inc.
Dental · 45d
Cleared Sep 14, 1990
SANOFLEX-STERILE LATEX SURGICAL GLOVES
K903513 · KGO
Lowenkamp Intl., Inc.
General Hospital · 42d