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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
95017–95040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1997
CAP-AID (IMPROVED)
K964580 · FHA
Nebel, Inc.
Gastroenterology & Urology · 56d
Cleared Jan 10, 1997
GAMMA-GLUTAMYL TRANSPEPTIDASE
K964916 · JQB
Derma Media Lab., Inc.
Chemistry · 32d
Cleared Jan 10, 1997
ANSPACH MICROMAX SYSTEM
K965080 · ERL
The Anspach Effort, Inc.
Ear, Nose, Throat · 22d
Cleared Jan 09, 1997
PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
K954331 · FPB
Pall Biomedical Products Co.
General Hospital · 482d
Cleared Jan 09, 1997
NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
K955393 · HIF
Surgical Innovations Plc
Obstetrics & Gynecology · 412d
Cleared Jan 09, 1997
AUTOLINK BODY PLETHYSMOGRAPH
K960121 · BZC
P.K. Morgan , Ltd.
Anesthesiology · 364d
Cleared Jan 09, 1997
LIGHTSTIC MODEL 360
K962965 · GEX
Rare Earth Medical, Inc.
General & Plastic Surgery · 163d
Cleared Jan 09, 1997
AMOILS EPITHELIAL SCRUBBER
K962989 · HOG
S. Percy Amoils
Ophthalmic · 161d
Cleared Jan 09, 1997
VOLLMAN PRONE POSITIONER
K963091 · IPT
Hill-Rom, Inc.
Physical Medicine · 154d
Cleared Jan 09, 1997
HERITAGE HIP SYSTEM
K963109 · JDI
Zimmer, Inc.
Orthopedic · 150d
Cleared Jan 09, 1997
MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL...
K963357 · MNH
Synthes (Usa)
Orthopedic · 136d
Cleared Jan 09, 1997
TENET RADIOLUCENT HAND TABLE
K963506 · FQO
Tenet Medical Engineering
General & Plastic Surgery · 128d
Cleared Jan 09, 1997
AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE
K964133 · KLE
American Dental Products, Inc.
Dental · 86d
Cleared Jan 09, 1997
MINI-SYMM BIPOLAR COAGULATOR
K964143 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 84d
Cleared Jan 09, 1997
SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL...
K964179 · EBF
S.S. White Mfg., Ltd.
Dental · 83d
Cleared Jan 09, 1997
SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION
K964259 · JDO
Synthes (Usa)
Orthopedic · 76d
Cleared Jan 09, 1997
EYECHEK
K964290 · HLQ
Reichert Ophthalmic Instruments, Div....
Ophthalmic · 73d
Cleared Jan 09, 1997
GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)
K964321 · LYZ
Shijiazhuang Hongray Plastic Products...
General Hospital · 72d
Cleared Jan 09, 1997
RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
K964338 · HKM
Rudolf Riester GmbH & Co. KG
Ophthalmic · 70d
Cleared Jan 09, 1997
DAVIS BAYONET ELECTRODES
K964602 · GEI
Valleylab, Inc.
General & Plastic Surgery · 52d
Cleared Jan 09, 1997
PANOGAUZE NON-WOVEN HYDROGEL DRESSING
K964620 · MGQ
Sage Pharmaceuticals, Inc.
General & Plastic Surgery · 52d
Cleared Jan 09, 1997
SURETEMP
K964643 · FLL
Diatek Instruments, Inc.
General Hospital · 58d
Cleared Jan 09, 1997
LACTATE DEHYDROGENASE
K964912 · CFJ
Derma Media Lab., Inc.
Chemistry · 31d
Cleared Jan 09, 1997
VIDAS PROESTERONE (PRG) (30 409)
K965084 · JLS
bioMerieux, Inc.
Chemistry · 21d