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
126025–126048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1990
CU-75 VISIBLE LIGHT-CURING UNIT
K900135 · EBZ
Kab Gloves Unltd.
Dental · 117d
Cleared May 07, 1990
MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
K900194 · OXO
Imt America, Inc.
Radiology · 111d
Cleared May 07, 1990
UNITY DENTAL CEMENT
K900342 · EMA
Whaledent Intl. Div. Ipco
Dental · 104d
Cleared May 07, 1990
THERMOAIRE SPLINT (TM) (TAS)
K900356 · ILO
Life Enhancement Technologies, LLC
Physical Medicine · 102d
Cleared May 07, 1990
MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES
K900388 · HBE
Midas Rex Pneumatic Tools, Inc.
Radiology · 98d
Cleared May 07, 1990
DISP. ELECTROSURGERY PENCIL, HAND CONTROL
K900633 · GEI
Medical/Surgical Specialties, Ltd.
General & Plastic Surgery · 88d
Cleared May 07, 1990
TS-1800 MEDICATION TRANSFER SPIKE
K900651 · FPA
The Medi-Dose Group
General Hospital · 87d
Cleared May 07, 1990
STEEROCATH(TM)
K900765 · DRF
Ep Technologies, Inc.
Cardiovascular · 80d
Cleared May 07, 1990
OTT INSUFFLATION FILTER TUBING
K900878 · HIF
Gynescope Corp.
Obstetrics & Gynecology · 70d
Cleared May 07, 1990
AMCATH SUCTION-IRRIGATION TUBE
K900988 · HET
Intl. Medical, Inc.
Obstetrics & Gynecology · 66d
Cleared May 07, 1990
MIRROR SHIELD
K901053 · EKJ
Pulpdent Corp.
Dental · 63d
Cleared May 07, 1990
MODIFIED PROFILE II ACETABULAR CUP PROSTHESIS
K901087 · JDI
Depuy, Inc.
Orthopedic · 59d
Cleared May 07, 1990
MULTI-STRIP
K901228 · FKX
Bellhouse Medical, Inc.
Gastroenterology & Urology · 54d
Cleared May 07, 1990
DIGIFORMER HR DFP-50A
K901405 · JAA
Toshiba America Medical Systems, In.C
Radiology · 42d
Cleared May 07, 1990
VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000
K901602 · LNH
Resonex, Inc.
Radiology · 31d
Cleared May 07, 1990
MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI
K901620 · LNH
Instrumentarium Imaging, Inc.
Radiology · 32d
Cleared May 07, 1990
INAMED SMALL DRAIN SYSTEM
K901742 · GCY
Inamed Development Co.
General & Plastic Surgery · 20d
Cleared May 07, 1990
STERILE SUCTION TUBING SET
K901761 · BYY
Acacia Laboratories, Inc.
General Hospital · 19d
Cleared May 07, 1990
INAMED CONVERTIBLE DRAIN SYSTEM
K901764 · GCY
Inamed Development Co.
General & Plastic Surgery · 19d
Cleared May 07, 1990
AIR CUSHIONED AUTO WHEELCHAIR LIFT ACL-200/AG-Z2
K901794 · ING
Metal Dynamics Corp.
Physical Medicine · 18d
Cleared May 07, 1990
MARK IV FLOATATION THERAPY BED
K901890 · IOQ
Hydrothermic Floatation Systems, Inc.
Physical Medicine · 11d
Cleared May 04, 1990
NUFFIELD TOTAL KNEE
K892503 · JWH
Orthopedic Systems, Inc.
Orthopedic · 388d
Cleared May 04, 1990
CONDOM (RUBBER) CONTRACEPTIVE
K893039 · HIS
Chinteik Hygiene Products Co., Ltd.
Obstetrics & Gynecology · 375d
Cleared May 04, 1990
FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM
K896288 · FFT
Oakfield Instruments, Ltd.
Gastroenterology & Urology · 186d