FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127369–127392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 13, 1990
GRANDCOR/CARDIOLINE ECT STRESS TESTING
K895547 · DSI
Grandcor Medical Systems
Cardiovascular · 181d
Cleared Mar 13, 1990
L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET
K895824 · FPD
Intl. Medical Marketing, Inc.
Gastroenterology & Urology · 165d
Cleared Mar 13, 1990
CURITY(R) PERCUTANEOUS CATHETERS
K895972 · DQY
Kendall Healthcare Products Co....
Cardiovascular · 152d
Cleared Mar 13, 1990
INFANT FEEDING TUBE
K896559 · FPD
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 116d
Cleared Mar 13, 1990
L.T.C. REPLACEMENT GASTROSTOMY TUBE
K896621 · KCQ
Intl. Medical Marketing, Inc.
Dental · 112d
Cleared Mar 13, 1990
CORE BUILD UP COMPOSITE
K896950 · EBF
Confi-Dental Products Co.
Dental · 90d
Cleared Mar 13, 1990
ESCORT NON-INVASIVE BLOOD PRESSURE OPTION
K896958 · DXN
Medical Data Electronics
Cardiovascular · 89d
Cleared Mar 13, 1990
NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM
K897004 · DXG
Advanced Technology Laboratories, Inc.
Cardiovascular · 85d
Cleared Mar 13, 1990
ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)
K897115 · IZI
Toshiba America Medical Systems, In.C
Radiology · 77d
Cleared Mar 13, 1990
ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM
K897126 · CAC
Atrium Medical Corp.
Anesthesiology · 77d