FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89545–89568 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1998
KOALA VASCULAR CLAMPS AND INSERTS
K980002 · DXC
Boss Instruments, Ltd.
Cardiovascular · 167d
Cleared Jun 18, 1998
KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW
K981053 · LMD
Eastman Kodak Company
Radiology · 87d
Cleared Jun 18, 1998
MEDRAD NEUROVASCULAR COIL
K981094 · MOS
Medrad, Inc.
Radiology · 84d
Cleared Jun 18, 1998
STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT
K981167 · CAF
Dhd Healthcare Corp.
Anesthesiology · 78d
Cleared Jun 18, 1998
PLATINUM READING, REVIEW & ANALYSIS WORKSTATION
K981217 · LLZ
GE Medical Systems
Radiology · 76d
Cleared Jun 18, 1998
NFC NEEDLEFREE Y-SITE, MODEL 69970
K981547 · FPA
Filtertek, Inc.
General Hospital · 49d
Cleared Jun 18, 1998
NFC NEEDLEFREE CONNECTOR MODEL 69900
K981548 · FPA
Filtertek, Inc.
General Hospital · 49d
Cleared Jun 18, 1998
PHILIPS THORAVISION
K981657 · KPR
Philips Medical Systems North...
Radiology · 38d
Cleared Jun 17, 1998
COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO
K973864 · IZF
Pausch Corp.
Radiology · 251d
Cleared Jun 17, 1998
BABYLOG 8000 PLUS
K974176 · CBK
Drager, Inc.
Anesthesiology · 223d
Cleared Jun 17, 1998
EASY RIDER MICRO CATHETER
K974473 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 203d
Cleared Jun 17, 1998
BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM
K974885 · KWQ
Blackstone Medical, Inc.
Orthopedic · 169d
Cleared Jun 17, 1998
THE NETWORK SYSTEM
K980234 · LLZ
Medical Sni , Ltd.
Radiology · 146d
Cleared Jun 17, 1998
VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE
K981013 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 91d
Cleared Jun 17, 1998
SCOOP 1
K981080 · BTO
Transtracheal Systems
Anesthesiology · 85d
Cleared Jun 17, 1998
MEDITEC LINK
K981196 · HQF
Aesculap-Meditec North America
Ophthalmic · 90d
Cleared Jun 16, 1998
BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH
K974761 · EFW
John O. Butler Co.
Dental · 179d
Cleared Jun 16, 1998
HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER
K980144 · DXH
Aerotel, Ltd.
Cardiovascular · 152d
Cleared Jun 16, 1998
KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6
K980216 · KOJ
Kreativ, Inc.
Dental · 146d
Cleared Jun 16, 1998
PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID...
K980738 · FRN
Byron Medical
General Hospital · 111d
Cleared Jun 16, 1998
ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES
K981003 · KPO
International Medical Products, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 16, 1998
PALI-TRODE
K981015 · GZL
Preferred Instruments
Neurology · 90d
Cleared Jun 16, 1998
MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR...
K981046 · JXG
Medtronic PS Medical
Neurology · 88d
Cleared Jun 16, 1998
STABLE FLOW
K981157 · FPA
Cmed
General Hospital · 77d