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
122689–122712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 04, 1991
GAMMA 600 NUCLEAR MEDICINE COMPUTER
K903469 · IYX
Strichman Medical Equipment, Inc.
Radiology · 187d
Cleared Feb 04, 1991
NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR
K903639 · GEX
Nidek, Inc.
General & Plastic Surgery · 175d
Cleared Feb 04, 1991
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
K903731 · GWF
Teca, Inc.
Neurology · 172d
Cleared Feb 04, 1991
MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)
K903876 · BTR
Boston Medical Products, Inc.
Anesthesiology · 166d
Cleared Feb 04, 1991
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400
K903941 · IZI
Shimadzu Medical Systems
Radiology · 161d
Cleared Feb 04, 1991
EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS
K904990 · LBZ
Syva Co.
Toxicology · 90d
Cleared Feb 04, 1991
CONTORNO(R), MODELS E AND ST
K905108 · GEI
Palex Intl. SA
General & Plastic Surgery · 83d
Cleared Feb 04, 1991
OLYMPUS URINE PH
K905146 · JQY
Diagnostic Systems
Chemistry · 81d
Cleared Feb 04, 1991
STS(TM) FLUOROSCOPIC IMAGING MODULE
K905278 · JAA
Medstone Intl., Inc.
Radiology · 73d
Cleared Feb 04, 1991
BIOTROL BILIRUBIN C & T CONTROL
K905280 · JJX
Biotrol, USA, Inc.
Chemistry · 73d
Cleared Feb 04, 1991
OPUS T3 TEST SYSTEM
K905410 · CDP
Pb Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Feb 04, 1991
.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP
K905502 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 59d
Cleared Feb 04, 1991
LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY
K905814 · CGJ
London Diagnostics, Inc.
Chemistry · 38d
Cleared Feb 04, 1991
ABUSCREEN(R) ONLINE CALIBRATORS
K905828 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 48d