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
163441–163464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1981
STANDARD METHODS AGAR
K811321 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
POTATO DEXTROSE AGAR
K811322 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
NUTRIENT BROTH
K811323 · JSC
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
PHENYLETHANOL AGAR
K811324 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
SABOURAUD DEXTROSE AGAR
K811325 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
SABOURAUD LIQUID, BROTH MODIFIED
K811326 · JSD
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
SALMONELLA SHIGELLA AGAR
K811327 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
SCHAEDLER AGAR
K811328 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
HUMERAL FRACTURE CAST BRACE
K811343 · IQI
Deseret Medical, Inc.
Physical Medicine · 16d
Cleared May 27, 1981
SIRECUST 358
K803208 · DSI
Siemens Corp.
Cardiovascular · 160d
Cleared May 27, 1981
NITROGLYCERINE IV SET
K810317 · FPA
Abbott Laboratories
General Hospital · 110d
Cleared May 27, 1981
MODELS 5976/5977 PACEMAKER PULSE GENER
K810677 · DXY
Medtronic, Inc.
Cardiovascular · 75d
Cleared May 27, 1981
GASTRIN RADIOIMMUNOASSAY TEST
K810722 · CGC
Clinical Assays, Inc.
Chemistry · 71d
Cleared May 27, 1981
DENTMED V-PACKS
K810801 · EFQ
Univ. of Bristol Dental School
General & Plastic Surgery · 65d
Cleared May 27, 1981
AR-1 PHYSIOLOGICAL PRODESSOR
K810880 · HCC
Atlas Researches , Ltd.
Neurology · 57d
Cleared May 27, 1981
EMG 3510/EMG 3510D MYOFEEDBACK MONITORS
K810881 · HCC
Atlas Researches , Ltd.
Neurology · 57d
Cleared May 27, 1981
ASR-3520 SKIN RESPONSE MONITOR
K810882 · HCC
Atlas Researches , Ltd.
Neurology · 57d
Cleared May 27, 1981
HUCKSTEP INTRAMEDULLARY NAIL
K811017 · KTT
Downs Surgical , Ltd.
Orthopedic · 42d
Cleared May 27, 1981
APPOSE SKIN STAPLER
K811030 · GAG
Davis & Geck, Inc.
General & Plastic Surgery · 41d
Cleared May 27, 1981
PENTAX BRONCHOFIBERSCOPE #FB-15A
K811059 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 40d
Cleared May 27, 1981
BYPASS COIL
K811068 · KPY
G.D. Searle and Co.
Radiology · 40d
Cleared May 27, 1981
INTERMEDICS POLY FLEX ENDOCARDIAL PACING
K811106 · DTB
Intermedics, Inc.
Cardiovascular · 34d
Cleared May 27, 1981
MEDTRONIC PULSE GENERATOR
K811123 · DXY
Medtronic Vascular
Cardiovascular · 33d
Cleared May 27, 1981
BLADE, TONGUE
K811157
Dyn-A-Med Products
General & Plastic Surgery · 29d