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
157393–157416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1983
RENNCO MODEL LS LIFT SEAL HEAT SEALER
K830540 · FRG
Rennco, Inc.
General Hospital · 27d
Cleared Mar 17, 1983
HEMAQUIK II STAINING SOLUTION #55961
K830542 · IAF
Accra Laboratories, Inc.
Pathology · 23d
Cleared Mar 17, 1983
LUER LOCK TEMPERATURE SENSOR
K830552 · FLL
Mon-A-Therm, Inc.
General Hospital · 22d
Cleared Mar 17, 1983
CLEAN-FLUSH
K830572 · KYZ
Burron Medical Products, Inc.
General Hospital · 22d
Cleared Mar 17, 1983
LYMPHANGIOGRAPHY SET
K830576 · DQO
Vertex Medical Corp.
Cardiovascular · 22d
Cleared Mar 17, 1983
MILLONIG'S MODIFIED PHOSPHATE BUFFERED
K830582 · IFP
Surgipath Medical Industries, Inc.
Pathology · 22d
Cleared Mar 17, 1983
NEUTRAL BUFFERED FORMALIN 10%
K830583 · IFP
Surgipath Medical Industries, Inc.
Pathology · 22d
Cleared Mar 17, 1983
BLEEDING TIME DEVICE DISPOSABLE
K830645 · JCA
American Dade
Hematology · 16d
Cleared Mar 17, 1983
SUTTER CPM 2000
K830649 · BXB
Sutter Biomedical, Inc.
Physical Medicine · 16d
Cleared Mar 17, 1983
CLEARIUM, MOUNTING MEDIUM
K830659 · KEP
Surgipath Medical Industries, Inc.
Pathology · 15d
Cleared Mar 17, 1983
STERILE SURGICAL DRAPES
K830660 · KKX
Phoenix Glove Co.
General Hospital · 15d
Cleared Mar 17, 1983
ULTRASONIC ECHOSCOPE
K837171
Ausonics Pty , Ltd.
Radiology · 29d
Cleared Mar 17, 1983
ARMEX LS-51
K837175
Elscint, Inc.
Radiology · 29d
Cleared Mar 17, 1983
EXOR LS-24
K837176
Elscint, Inc.
Radiology · 29d
Cleared Mar 17, 1983
CONTROLLEX LS-5
K837177
Elscint, Inc.
Radiology · 29d
Cleared Mar 17, 1983
TAURUS LS THREE-PHASE GENERATORS
K837179
Elscint, Inc.
Radiology · 29d
Cleared Mar 17, 1983
TREPHIX THREE PHSE GENERATORS AND EXONON SINGLE PHASE GENERATORS
K837180
Elscint, Inc.
Radiology · 29d
Cleared Mar 17, 1983
TOMAX LS-20
K837182
Elscint, Inc.
Radiology · 29d
Cleared Mar 17, 1983
HI-LO RADIOLOGICAL STRETCHER
K837183
Elscint, Inc.
Radiology · 29d
Cleared Mar 16, 1983
MEDTRONIC MODELS 59401 5941
K823831 · DXY
Medtronic Vascular
Cardiovascular · 85d
Cleared Mar 16, 1983
PACEMAKER ELECTRODE PERM. & TEMP
K830464 · DTB
Daig Corp.
Cardiovascular · 29d
Cleared Mar 16, 1983
CATHETER CONNECTION W/INTEGRAL INJECTATE
K830523 · DQO
Gould, Inc.
Cardiovascular · 27d
Cleared Mar 15, 1983
SPLIT COLON STIFFENING TUBE
K830247 · FED
Keymed, Inc.
Gastroenterology & Urology · 49d
Cleared Mar 14, 1983
MODEL 2100 FETAL MONITOR
K837102
Huntleigh Group , Ltd.
Radiology · 66d