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
126769–126792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1990
AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING
K900821 · LRG
Bd Becton Dickinson Vacutainer...
Microbiology · 22d
Cleared Mar 15, 1990
MJ PERCUSSOR(TM)
K901026 · BYI
Merced Medical, Inc.
Anesthesiology · 9d
Cleared Mar 14, 1990
HEARING AID (ALL-IN-THE-EAR)
K893004 · ESD
Hearing Specialists of Nevada, Inc.
Ear, Nose, Throat · 324d
Cleared Mar 14, 1990
SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH
K895017 · DXG
Sorba Medical Systems, Inc.
Cardiovascular · 218d
Cleared Mar 14, 1990
S-ROM/NOILES MARK 3
K896048 · KRO
Joint Medical Products Corp.
Orthopedic · 147d
Cleared Mar 14, 1990
ONCOPROBE II SYSTEM
K896588 · IZD
Care Wise Medical Products Corp.
Radiology · 113d
Cleared Mar 14, 1990
TD-28 DISPOSABLE ELECTRODE
K896766 · GXY
Med USA
Neurology · 103d
Cleared Mar 14, 1990
ALL-BOND DENTIN BONDING SYSTEM
K897020 · KLE
Bisco, Inc.
Dental · 85d
Cleared Mar 14, 1990
TEETHMATE-A
K897027 · EBC
Kuraray Co.
Dental · 86d
Cleared Mar 14, 1990
DISPOSABLE PROPHY ANGLE AND ACCESSORIES
K897101 · EFB
Dentsply Intl.
Dental · 83d
Cleared Mar 14, 1990
OPTIMA MPT MODEL 5281E AND MODEL 5282E
K897116 · DXY
Telectronics Pacing Systems, Inc.
Cardiovascular · 78d
Cleared Mar 14, 1990
3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS
K897184 · DXE
Cathlab Corp.
Cardiovascular · 76d
Cleared Mar 14, 1990
MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID
K900050 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 70d
Cleared Mar 14, 1990
MCT COMPOSITE CHAIR
K900191 · IOR
Medical Composite Technology, Inc.
Physical Medicine · 57d
Cleared Mar 14, 1990
SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES
K900296 · KGO
P.T. Latexindo Prautama
General Hospital · 51d
Cleared Mar 14, 1990
QUATTRO CATHETER
K900452 · DRF
Ep Technologies, Inc.
Cardiovascular · 43d
Cleared Mar 14, 1990
OPUS MODEL 4021, VVI, 5MM UNIPOLAR
K900461 · DXY
Ela Medical, Inc.
Cardiovascular · 42d
Cleared Mar 14, 1990
TECHNICON H*2(TM) SYSTEM
K900593 · GKZ
Technicon Instruments Corp.
Hematology · 35d
Cleared Mar 14, 1990
DAHLBERG MODEL JMS IN-THE-EAR HEARING INSTRUMENT
K900692 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Mar 14, 1990
POWERED INFLATABLE TUBE MASSAGER, SPORT-MED
K901022 · IRP
Damor America, Inc.
Physical Medicine · 9d
Cleared Mar 13, 1990
SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS
K894300 · FIP
U.S. Filter/Continental Water Systems
Gastroenterology & Urology · 264d
Cleared Mar 13, 1990
AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION
K895297 · CAC
Boehringer Laboratories
Anesthesiology · 200d
Cleared Mar 13, 1990
ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG
K895468 · LJC
Orgenics, Ltd.
Microbiology · 183d
Cleared Mar 13, 1990
LINK GIEBEL BLADE PLATE SYSTEM
K895507 · KTT
Link America, Inc.
Orthopedic · 183d