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
123457–123480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1990
JAIN GRAFT ASSIST
K904536 · GCZ
Jain Surgical Equipment, Inc.
General & Plastic Surgery · 56d
Cleared Nov 29, 1990
IVT RAST TRACER
K904661 · DHB
In Vitro Technologies, Inc.
Immunology · 48d
Cleared Nov 29, 1990
ELEGANCE FERRITIN ELISA
K904822 · DBF
Bioclone Australia Pty , Ltd.
Immunology · 36d
Cleared Nov 29, 1990
FLEXI-TRAK(TM) ANCHORING DEVICE
K905128 · KNY
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 15d
Cleared Nov 29, 1990
RUBBER LATEX SURGICAL GLOVES, STERILE
K905161 · KGO
Rfb Latex Pvt. , Ltd.
General Hospital · 13d
Cleared Nov 28, 1990
NORPLANT(R) TROCAR
K903490 · FMI
Wyeth-Ayerst Laboratories, Inc.
General Hospital · 127d
Cleared Nov 28, 1990
HYCOR ACCUPINCH METHAMPHETAMINE TEST
K904115 · DKZ
Hycor Biomedical, Inc.
Toxicology · 83d
Cleared Nov 28, 1990
BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT
K904184 · LBR
Biotron U.S.A., Inc.
Chemistry · 77d
Cleared Nov 28, 1990
STRATUS PRIMIDONE FLUOROMETRIC ENZYME
K904683 · LFT
Baxter Healthcare Corp
Chemistry · 44d
Cleared Nov 28, 1990
SECONDARY CALIBRATORS
K904698 · JIT
Bionostics, Inc.
Chemistry · 43d
Cleared Nov 28, 1990
EMIT (R) II PHENCYCLIDINE ASSAY
K904765 · LCM
Syva Co.
Toxicology · 37d
Cleared Nov 28, 1990
TORQUE FRAME QTF1000
K904898 · IKK
Medmetric Corp.
Physical Medicine · 29d
Cleared Nov 28, 1990
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE
K904995 · KLN
Roche Diagnostic Systems, Inc.
Toxicology · 21d
Cleared Nov 28, 1990
EZ-SCREEN:BARBITURATES
K905057 · DIS
Environmental Diagnostics, Inc.
Toxicology · 20d
Cleared Nov 28, 1990
GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138
K905096 · JQB
Amresco, Inc.
Chemistry · 15d
Cleared Nov 27, 1990
MOTO-MED RF-II AND PICO
K893924 · BXB
Holl Meditronics, Inc.
Physical Medicine · 545d
Cleared Nov 27, 1990
FLEXIFLO STOMATE DECOMPRESSION TUBE
K903579 · KNT
Abbott Laboratories
Gastroenterology & Urology · 111d
Cleared Nov 27, 1990
SINGLE LUMEN CATHETERS, MODIFICATION
K904140 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 82d
Cleared Nov 27, 1990
ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS
K904156 · LZV
Origin Medsystems, Inc.
Orthopedic · 81d
Cleared Nov 27, 1990
RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330
K904210 · LIF
Minntech Corp.
Gastroenterology & Urology · 76d
Cleared Nov 27, 1990
SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
K904299 · FGD
E-Z-Em, Inc.
Gastroenterology & Urology · 69d
Cleared Nov 27, 1990
UROLAB JANUS
K904386 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 64d
Cleared Nov 27, 1990
CARESS MASSAGER
K904915 · ISA
Kendex Corp.
Physical Medicine · 27d
Cleared Nov 27, 1990
BIO MEDX AIR FLOTATION SYSTEM
K905156 · IOQ
Bio Clinic Co.
Physical Medicine · 12d