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
123265–123288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 05, 1991
ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC
K904088 · DQA
Sentinel
Anesthesiology · 153d
Cleared Feb 05, 1991
INTERPORE CYLINDRICAL HEX IMPLANT
K904611 · DZE
Interpore Intl.
Dental · 117d
Cleared Feb 05, 1991
MINNILERT AIR DETECTOR
K904992 · FJF
Minntech Corp.
Gastroenterology & Urology · 90d
Cleared Feb 05, 1991
CUP OUT
K905027 · HSZ
Anspach Mfg., Inc.
Orthopedic · 90d
Cleared Feb 05, 1991
SUNGLASSES
K905041 · HQY
Eskco, Inc.
Ophthalmic · 90d
Cleared Feb 05, 1991
CARDIOPULMONARY BYPASS VASCULAR CATHETER
K905224 · DWF
3M Health Care, Sarns
Cardiovascular · 77d
Cleared Feb 05, 1991
MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE
K905446 · DRX
Medtronic Andover Medical, Inc.
Cardiovascular · 62d
Cleared Feb 05, 1991
SOFTOUCH GUIDING CATHETER
K905547 · DQY
Mallinckrodt Medical
Cardiovascular · 56d
Cleared Feb 05, 1991
PALMAZ BILIARY STENT
K905720 · DQY
Johnson & Johnson Interventional Systems
Cardiovascular · 46d
Cleared Feb 05, 1991
PHILIPS MODEL S47 BTE HEARING AID
K910206 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 20d