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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
88657–88680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1998
POWDERED GREEN NITRILE EXAMINATION GLOVES
K981674 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 77d
Cleared Jul 28, 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981675 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 77d
Cleared Jul 28, 1998
HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y
K981683 · FPA
Venusa , Ltd.
General Hospital · 76d
Cleared Jul 28, 1998
C0-AXIAL INTRODUCER NEEDLE
K981721 · KNW
Inrad
Gastroenterology & Urology · 74d
Cleared Jul 28, 1998
VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
K981827 · FET
Angiolaz, Inc.
Gastroenterology & Urology · 67d
Cleared Jul 28, 1998
UREA
K981918 · CDQ
Abbott Laboratories
Chemistry · 57d
Cleared Jul 28, 1998
CT 100 ELECTROCARDIOGRAPH
K981951 · DPS
Macquarie Medical Systems
Cardiovascular · 90d
Cleared Jul 27, 1998
MCS-MEDICATED CANAL SEALER
K973636 · EMA
Dr. Howard Martin, P.A.
Dental · 306d
Cleared Jul 27, 1998
PHOTON RADIOSURGERY SYSTEM PRS400
K980526 · JAD
Pec Photoelectron Corp.
Radiology · 167d
Cleared Jul 27, 1998
EUP-OL334 LAPARASCOPICPROBE
K981434 · ITX
Hitachi Medical Corp. of America
Radiology · 97d
Cleared Jul 27, 1998
MENISCAL REPAIR DEVICE
K981692 · MBI
Linvatec Corp.
Orthopedic · 75d
Cleared Jul 27, 1998
MPS RESERVOIR BAG
K982048 · KPE
Medical Product Specialists
General Hospital · 47d
Cleared Jul 26, 1998
3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360
K974445 · DRX
3M Healthcare
Cardiovascular · 243d
Cleared Jul 25, 1998
MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
K982232 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 30d
Cleared Jul 24, 1998
RESOR-PIN RESORBABLE MEMBRANE PIN
K972817 · LYC
Geistlich-Pharma
Dental · 360d
Cleared Jul 24, 1998
BALADI INVERTER WITH COAXIAL AORTIC PUNCH
K980128 · DXC
Cardio Medical Solutions, Inc.
Cardiovascular · 191d
Cleared Jul 24, 1998
MOBETRON
K981112 · LHN
Intraop Medical, Inc.
Radiology · 120d
Cleared Jul 24, 1998
OTO WIZZARD
K981511 · EWO
Medrx, Inc.
Ear, Nose, Throat · 87d
Cleared Jul 24, 1998
LIQUID ENZYME ID 90133
K981561 · LPN
Alcon Laboratories
Ophthalmic · 84d
Cleared Jul 24, 1998
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM
K981736 · MDB
Organon Teknika Corp.
Microbiology · 67d
Cleared Jul 24, 1998
CARRIAZO BARRAQUER MICROKERATOME
K981741 · HMY
Moria, Inc.
Ophthalmic · 67d
Cleared Jul 24, 1998
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K981774 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 65d
Cleared Jul 24, 1998
XENON LIGHT SOURCE MODEL LS6000
K981804 · GCT
Contec Medical Vision, Ltd.
Gastroenterology & Urology · 64d
Cleared Jul 24, 1998
SENSITEX EXAMINATION GLOVE
K981963 · LYZ
Oak Carolina, Inc.
General Hospital · 50d