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
122665–122688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1991
CONTAIN(TM)
K895859 · GCX
Arbor Technologies, Inc.
General Hospital · 492d
Cleared Feb 07, 1991
THE WONDER BOX
K901797 · GWL
Micro Tronics Corp.
Neurology · 294d
Cleared Feb 07, 1991
ABBOTT VISION(TM) GLYCATED HB
K904027 · LCP
Abbott Laboratories
Hematology · 161d
Cleared Feb 07, 1991
BARD UTERINE MANIPULATOR
K904079 · LKF
C.R. Bard, Inc.
Obstetrics & Gynecology · 155d
Cleared Feb 07, 1991
ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS
K904689 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 120d
Cleared Feb 07, 1991
WEP-8430A TELEMETRY CENTRAL STATION
K904696 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 176d
Cleared Feb 07, 1991
DIGITAL THERMOMETER KITS
K905025 · FLL
Abco Dealers, Inc.
General Hospital · 92d
Cleared Feb 07, 1991
ALTAIR
K905072 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 90d
Cleared Feb 07, 1991
FLO-RESTER(R) VESSEL SIZER
K905159 · DWP
Bio-Vascular, Inc.
Cardiovascular · 83d
Cleared Feb 07, 1991
MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A
K905251 · FRN
Medical Technical Products
General Hospital · 78d
Cleared Feb 07, 1991
SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER
K905458 · DQE
Baxter Healthcare Corp
Cardiovascular · 64d
Cleared Feb 07, 1991
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
K905636 · DHB
Ventrex Laboratories, Inc.
Immunology · 52d
Cleared Feb 07, 1991
CANMED 451
K905729 · DRX
Andover Medical, Inc.
Cardiovascular · 45d
Cleared Feb 07, 1991
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K905853 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 51d
Cleared Feb 07, 1991
SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH
K910155 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 24d
Cleared Feb 06, 1991
A PHYSIOTHERAPY APPARATUS
K902803 · ILY
Grace River Ent., Inc.
Physical Medicine · 224d
Cleared Feb 06, 1991
SENSIDERM
K904244 · KGO
Ansell Intl.
General Hospital · 145d
Cleared Feb 06, 1991
SKIN MARKER
K905143 · FZZ
Aesculap, Inc.
General & Plastic Surgery · 83d
Cleared Feb 06, 1991
VESSELOOPS
K905240 · KDC
Sparta Surgical Corp.
General & Plastic Surgery · 78d
Cleared Feb 06, 1991
INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM
K905365 · KYZ
Instrument Makar, Inc.
General Hospital · 77d
Cleared Feb 06, 1991
STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY
K905460 · HMT
Angiosystems, Inc.
General Hospital · 63d
Cleared Feb 06, 1991
PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES
K905462 · LRP
Angiosystems, Inc.
General & Plastic Surgery · 63d
Cleared Feb 06, 1991
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH
K905861 · CFE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 37d
Cleared Feb 05, 1991
SONICAID MODEL MERIDIAN 800
K902690 · HGM
Oxford Medilog, Inc.
Obstetrics & Gynecology · 231d