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
89041–89064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 16, 1998
INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER
K981193 · MBI
Innovasive Devices, Inc.
Orthopedic · 75d
Cleared Jun 16, 1998
ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST
K981197 · DKZ
Tcpi, Inc.
Toxicology · 75d
Cleared Jun 16, 1998
WATER FILLED GUM SOOTHER
K981202 · KKO
Corium Corp.
Dental · 75d
Cleared Jun 16, 1998
ALLOYBOND
K981383 · KLE
Southern Dental Industries, Inc.
Dental · 61d
Cleared Jun 16, 1998
KERR HARD DENTURE RELINE MATERIAL
K981448 · EBI
Sybron Dental Specialties, Inc.
Dental · 55d
Cleared Jun 16, 1998
GC FUJI BOND LC
K981514 · KLE
GC America, Inc.
Dental · 49d
Cleared Jun 16, 1998
CA
K981578 · CJY
Abbott Laboratories
Chemistry · 43d
Cleared Jun 16, 1998
AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000
K981754 · CBN
Porter Instrument Co., Inc.
Anesthesiology · 29d
Cleared Jun 16, 1998
PHOS
K981759 · CEO
Abbott Laboratories
Chemistry · 28d