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
164977–165000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1980
SYNTHES SPINAL IMPLANT SYSTEM
K802462 · KWP
Synthes (Usa)
Orthopedic · 69d
Cleared Dec 16, 1980
DPA 207 PERSONAL
K802513 · KCX
Hill, Farrer & Borrill
General & Plastic Surgery · 62d
Cleared Dec 16, 1980
CYE BIPHASIC BLOOD CULTURE MEDIUM
K802571 · JSJ
Remel Co.
Microbiology · 60d
Cleared Dec 16, 1980
ORTRON 90* HIP PROSTHESIS
K802627 · JDI
Cintor Orthopaedic Div.
Orthopedic · 54d
Cleared Dec 16, 1980
POLYCARBONATE TEMPORARY CEMENT
K802662 · EMA
Buffalo Dental Mfg. Co., Inc.
Dental · 49d
Cleared Dec 16, 1980
ARGYLE CLOSED URINARY DRAINAGE SET
K802667 · KNX
Sherwood Medical Co.
Gastroenterology & Urology · 49d
Cleared Dec 16, 1980
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S
K802719 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 46d
Cleared Dec 16, 1980
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S
K802720 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 46d
Cleared Dec 16, 1980
FIBER OPTIC ADAPTER CAT#60-0898
K802766 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC LIGHT GUIDE CAT#60-0768
K802767 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC ADAPTER #60-0897
K802768 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC ADAPTER #60-895
K802771 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC ADAPTER #60-0894
K802772 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC LIGHT GUIDE #60-0767
K802773 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC ADAPTER #60-0892
K802774 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC ADAPTER #60-0896
K802775 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
SURGEONS CHOICE STAPLE, REMOVE/IMPLANT
K802783 · GBN
Hospital Products Intl.
General & Plastic Surgery · 42d
Cleared Dec 16, 1980
OXYGEN SATURATION METER MODEL NO. SM-1
K802847
Bentley Laboratories, Inc.
Cardiovascular · 34d
Cleared Dec 16, 1980
TECNOL TELEMETRY UNIT POUCH
K802849 · DRG
Tecnol New Jersey Wound Care, Inc.
Cardiovascular · 34d
Cleared Dec 16, 1980
ARGYLE HEMATURIA BALLOON CATHETER
K802875 · KOD
Sherwood Medical Co.
Gastroenterology & Urology · 29d
Cleared Dec 16, 1980
MODEL EEG 4221
K802887 · GWQ
Nihon Kohden America, Inc.
Neurology · 29d
Cleared Dec 16, 1980
ELECTRONIC DIGITAL THERMOMETER
K802897 · KPD
Philip J. Teders
General Hospital · 29d
Cleared Dec 16, 1980
WILLIAM HARVEY OXYGENATING GAS FILTER
K802906 · KRI
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Dec 15, 1980
VIDA 55 PULSE-ECHO ULTRASONIC DEVICE
K802279 · EWG
Vida, Inc.
Ear, Nose, Throat · 88d