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
147937–147960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1985
CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS
K844360 · DXY
Cordis Corp.
Cardiovascular · 217d
Cleared Jun 18, 1985
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYS ND:YAG
K850018 · GEX
Laserscope
General & Plastic Surgery · 167d
Cleared Jun 18, 1985
SOF. CARE CUSHION & SOF-CARE CUSHION COVER
K851027 · KIC
Gaymar Industries, Inc.
Physical Medicine · 98d
Cleared Jun 18, 1985
VARIABLE NEBULIZER HEATER
K851074 · CAF
Travenol Laboratories, S.A.
Anesthesiology · 92d
Cleared Jun 18, 1985
LODE MODEL CORIVAL ERGOMETER
K851097 · ISD
Lode Corp.
Physical Medicine · 91d
Cleared Jun 18, 1985
TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE
K851175 · GXY
Medical Devices, Inc.
Neurology · 85d
Cleared Jun 18, 1985
T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER
K851215 · CAM
Penox Technologies, Inc.
Anesthesiology · 84d
Cleared Jun 18, 1985
PENOX DUAL FEED MANIFOLD
K851216 · CAM
Penox Technologies, Inc.
Anesthesiology · 84d
Cleared Jun 18, 1985
PENOX DUAL FLOW MINIFOLD
K851217 · CAM
Penox Technologies, Inc.
Anesthesiology · 84d
Cleared Jun 18, 1985
FILL HOSE SAFETY ADAPTER
K851219 · CAM
Penox Technologies, Inc.
Anesthesiology · 84d
Cleared Jun 18, 1985
MICRO-INHALER MODEL TV-7000 & TV-8000
K851254 · CCQ
Bioclimatic, Inc.
Anesthesiology · 82d
Cleared Jun 18, 1985
OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES
K851404 · KWA
Osteonics Corp.
Orthopedic · 70d
Cleared Jun 18, 1985
NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC.
K851981 · FOZ
Superior Plastic Products Corp.
General Hospital · 42d
Cleared Jun 18, 1985
MANAN UBK ULTRASONIC GUIDED BIOPSY KIT
K852105 · FCH
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 34d
Cleared Jun 18, 1985
NON-STERILE GAUZE ROLLER BANDAGES
K852265 · EFQ
Leonard Joseph Co.
General & Plastic Surgery · 25d
Cleared Jun 18, 1985
ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES
K852267 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 21d
Cleared Jun 18, 1985
MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)
K852334 · HLJ
Design Med. Corp.
Ophthalmic · 18d
Cleared Jun 18, 1985
LIDGRER-LUND ACETABULAR SOCKETS
K852369 · JDL
Link America, Inc.
Orthopedic · 14d
Cleared Jun 17, 1985
BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH
K850144 · FRC
American Sterilizer Co.
General Hospital · 154d
Cleared Jun 17, 1985
EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
K850431 · KHE
Nms Pharmaceuticals, Inc.
Hematology · 133d
Cleared Jun 17, 1985
HOME BILI LIGHTS-MODEL 100
K850599 · LBI
Physician Engineered Products, Inc.
General Hospital · 122d
Cleared Jun 17, 1985
RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI
K851285 · DCF
Cooper Biomedical, Inc.
Immunology · 77d
Cleared Jun 17, 1985
FORTUNA DISPOSABLE SYRINGES
K851519 · FMF
Impor-Tex, Intl., Inc.
General Hospital · 63d
Cleared Jun 17, 1985
TROCAR CATHETER
K851979 · JOL
Hospital Products Group
General Hospital · 41d