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
125857–125880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1990
FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM)
K900824 · EJF
Midwest Orthodontic Mfg.
Dental · 90d
Cleared May 22, 1990
NON STERILE PARENTERAL SUPPLY KIT
K900857 · FMF
Intermed, Inc.
General Hospital · 88d
Cleared May 22, 1990
COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)
K900910 · DTW
Cobe Laboratories, Inc.
Cardiovascular · 84d
Cleared May 22, 1990
O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES
K901002 · HQX
Oculo Plastik, Inc.
Ophthalmic · 81d
Cleared May 22, 1990
FLEXIBLE CHOLEDOCHOSCOPE
K901010 · FBN
Intramed Laboratories, Inc.
Gastroenterology & Urology · 78d
Cleared May 22, 1990
SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000
K901061 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 78d
Cleared May 22, 1990
MEDISONIC HUMDIFIER/INHALER
K901114 · CAF
Medisonic U.S.A., Inc.
Anesthesiology · 76d
Cleared May 22, 1990
KOAGULAB 60-S COAGULATION SYSTEM
K901120 · GKP
Ortho Diagnostic Systems, Inc.
Hematology · 71d
Cleared May 22, 1990
SARA SATCAP
K901132 · CCK
Ppg Industries, Inc.
Anesthesiology · 71d
Cleared May 22, 1990
MODEL 9101 RECORDER/ANALYZER SYSTEM
K901251 · DSH
Aequitron Medical, Inc.
Cardiovascular · 67d
Cleared May 22, 1990
DOMED AND FINNED ACETABULAR COMPONENT
K901328 · JDI
Orthomet, Inc.
Orthopedic · 62d
Cleared May 22, 1990
KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM
K901338 · JWH
Kirschner Medical Corp.
Orthopedic · 61d
Cleared May 22, 1990
USCI(R) ACCESS(TM) INTRODUCER SET
K901452 · DYB
C.R. Bard, Inc.
Cardiovascular · 55d
Cleared May 22, 1990
LSF(TM) TOTAL HIP SYSTEM
K901460 · JDI
Implant Technology, Inc.
Orthopedic · 55d
Cleared May 22, 1990
DNP 60-B UNIPOLAR ENDOCARDIAL LEAD
K901709 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 39d
Cleared May 22, 1990
KLEIN MICRO-CANNULA HANDLE(TM)
K901719 · GEA
Jeff Klein Surgical, Inc.
General & Plastic Surgery · 39d
Cleared May 22, 1990
HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL
K901774 · DQA
Mennen Medical, Inc.
Anesthesiology · 33d
Cleared May 21, 1990
PATIENT EXAM GLOVES (MFG. KOON SENG)
K893071 · LYY
Innovative Medical Suppliers
General Hospital · 403d
Cleared May 21, 1990
SIEMENS MODEL 284 PP-L
K893573 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 284 PP-AGC
K893574 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 283 ASP
K893575 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 284 PP
K893576 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
K900908 · HIG
Zimmer, Inc.
Obstetrics & Gynecology · 83d
Cleared May 21, 1990
OMNIPATCH
K900941 · HOY
Eye Garter Company, Inc.
Ophthalmic · 82d