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
142105–142128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1986
URESIL OCCLUSION BALLOON CATHETER
K863559 · DQT
Uresil Corp.
Cardiovascular · 28d
Cleared Oct 10, 1986
URESIL IRRIGATION CATHETER
K863564 · DQY
Uresil Corp.
Cardiovascular · 28d
Cleared Oct 10, 1986
ENDOPHOTOCOAGULATION PROBE
K863591 · HQF
Mira, Inc.
Ophthalmic · 25d
Cleared Oct 10, 1986
POLAREX AND POLAREX MLD
K863651 · HQY
Selex, Inc.
Ophthalmic · 22d
Cleared Oct 10, 1986
PATHFINDER(TM) SPECIMEN COLLECTION KIT
K863682 · JSM
Kallestad Laboratories, Inc.
Microbiology · 21d
Cleared Oct 10, 1986
OPHTHALMIC FITLER MICRO CAPSULE
K863729 · HQC
Ipax, Inc.
Ophthalmic · 17d
Cleared Oct 09, 1986
DENTAL ANESTHESIA APPARATUS
K850425 · KZM
Pain Prevention, Inc.
Dental · 612d
Cleared Oct 09, 1986
PHONIC EAR, MODEL PE475R
K862773 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 79d
Cleared Oct 09, 1986
HOSPITAL BED
K863748 · FNJ
Global Medical Prods, Inc.
General Hospital · 15d
Cleared Oct 09, 1986
AMEBIASIS MICROASSAY
K863811 · KHW
Diamedix Corp.
Microbiology · 9d
Cleared Oct 09, 1986
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
K863821 · JTZ
Gibco Laboratories Life Technologies,...
Microbiology · 9d
Cleared Oct 08, 1986
CSI/MPR OR CSI/MPR PLUS
K861852 · LLZ
Columbia Scientific, Inc.
Radiology · 147d
Cleared Oct 08, 1986
READS RF TEST KIT FOR IGM RHEUMATOID FACTOR
K863238 · DHR
Biostar Medical Products, Inc.
Immunology · 48d
Cleared Oct 08, 1986
TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY
K863345 · DBF
Hybritech, Inc.
Immunology · 40d
Cleared Oct 08, 1986
MODIFICATION OF STERILITY CYCLE PARAMETERS
K863365 · DXY
Coratomic, Inc.
Cardiovascular · 36d
Cleared Oct 08, 1986
CORDIS MULTICOR II MODEL 402D PACER
K863417 · DXY
Cordis Corp.
Cardiovascular · 35d
Cleared Oct 08, 1986
MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)
K863582 · DXY
Cook Pacemaker Corp.
Cardiovascular · 23d
Cleared Oct 08, 1986
MODIFIED GAS SAMPLING KIT
K863640 · CCK
Respiratory Support Products, Inc.
Anesthesiology · 35d
Cleared Oct 08, 1986
DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300
K863820 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 8d
Cleared Oct 07, 1986
SCREW-VENT (TM) IMPLANT/ENDOSSEOUS SCREW IMPLANT
K861426 · DZE
Core-Vent Corp.
Dental · 174d
Cleared Oct 07, 1986
CT MAX, CATALOG NO. B7940 HA
K862317 · JAK
General Electric Co.
Radiology · 111d
Cleared Oct 07, 1986
PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT
K862447 · KHQ
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 102d
Cleared Oct 07, 1986
PUNCH BIOPSY KIT
K862562 · KNW
Clinipad Corp.
Gastroenterology & Urology · 96d
Cleared Oct 07, 1986
LDS - LASER DELIVERY SYSTEM
K862568 · HQF
Coherent Medical Group
Ophthalmic · 92d