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
152593–152616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1984
ETHOX RELIA-FLO 2001 ENTERAL FEED
K841512 · FRN
Ethox Corp.
General Hospital · 39d
Cleared May 21, 1984
JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II)
K841518 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 39d
Cleared May 21, 1984
HAEMOPHILUS ISOLATION AGAR 2827
K841673 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 28d
Cleared May 21, 1984
CAPILLARY GAS CHROMATOGRAPHIC COLUMNS
K841712 · DII
Supelco, Inc.
Chemistry · 27d
Cleared May 21, 1984
ENRICHED CULTURE MED. FLUID THIOGLYC0
K841837 · KZI
Microline Scientific
Microbiology · 34d
Cleared May 21, 1984
ENRICHED CULTURE MED. TRYPTIC SOY AGAR
K841838 · KZI
Microline Scientific
Microbiology · 34d
Cleared May 18, 1984
YAG LASER 8000 - LOWER GI APPLICAT
K840142 · LNK
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 133d
Cleared May 18, 1984
YAG LASER 8000 GASTROINTESTINAL BLEE
K840144 · FCG
Cooper Medical Corp.
Gastroenterology & Urology · 126d
Cleared May 18, 1984
CONTACT LENS CASE FOR RIGID GAS PERMA
K840691 · LRX
Optimum Manufacturers, Inc.
Ophthalmic · 92d
Cleared May 18, 1984
BURN BATH
K841397 · ILJ
Setma, Inc.
Physical Medicine · 45d
Cleared May 16, 1984
ARIES MEDICAL MODEL 700
K833632 · DSP
Aries Medical, Inc.
Cardiovascular · 212d
Cleared May 16, 1984
PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C
K840121 · DRS
Hewlett-Packard Co.
Cardiovascular · 126d
Cleared May 16, 1984
IMPLANTABLE PROGRAMMABLE PULSE GENER
K840737 · DXY
Telectronics, Inc.
Cardiovascular · 85d
Cleared May 16, 1984
UNIPAK 100 ANALYZER, 65156 & CHEMISTR
K840883 · JJE
Emd Chemicals, Inc.
Chemistry · 79d
Cleared May 16, 1984
HEARING AID AUDIO-STARR A
K840906 · ESD
Jade Electronics Corp.
Ear, Nose, Throat · 78d
Cleared May 16, 1984
QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE
K841073 · DXY
Intermedics, Inc.
Cardiovascular · 65d
Cleared May 16, 1984
CARDIAC PULSE GENERATOR 254-18
K841074 · DXY
Intermedics, Inc.
Cardiovascular · 65d
Cleared May 16, 1984
CARCIAC PULSE GENERATOR 254-20
K841075 · DXY
Intermedics, Inc.
Cardiovascular · 65d
Cleared May 16, 1984
FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000
K841087 · HRX
Machida America, Inc.
Orthopedic · 64d
Cleared May 16, 1984
CLAYMAN-PAREL CAPSULE COUPEUR
K841101 · HNY
Miami Eye Technology, Inc.
Ophthalmic · 64d
Cleared May 16, 1984
OEC/REZAIAN SPINAL FIXATOR
K841189 · KWQ
Orthopedic Equipment Co., Inc.
Orthopedic · 57d
Cleared May 16, 1984
FLATPACK CARRYING CASE
K841316
Bausch & Lomb, Inc.
Ophthalmic · 44d
Cleared May 16, 1984
RICHARDS FIXATOR SYSTEM
K841334 · JEC
Richards Medical Co., Inc.
Orthopedic · 44d
Cleared May 16, 1984
HYPERBARIC OXYGEN GURNEY-
K841368 · HST
Orthopedic Systems, Inc.
Neurology · 43d