Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
158233–158256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1983
PACING LEAD #PMA F 860
K830457 · DTB
Ela Medical, Inc.
Cardiovascular · 36d
Cleared Mar 17, 1983
JOHNSON & JOHNSON OPAQUE COLOR MODIFI
K830491 · EBE
Johnson & Johnson Professionals, Inc.
Dental · 30d
Cleared Mar 17, 1983
ESA ELECTROSURGICAL ARTHROSCOPY GENERA
K830499 · HRX
Concept, Inc.
Orthopedic · 29d
Cleared Mar 17, 1983
ZANLEX, ZAN-TEX & ZANDEX
K830511 · GDY
Winn Hirsch & Assoc.
General & Plastic Surgery · 28d
Cleared Mar 17, 1983
MONO SCREENING TEST
K830531 · KTN
Tago, Inc.
Immunology · 27d
Cleared Mar 17, 1983
INTRAVASCULAR CATHETER SET
K830539 · FOZ
Lab-A-Cath Corp.
General Hospital · 27d
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