FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
74665–74688 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2002
ULTRASTIM KIT
K013532 · GZJ
Axelgaard Mfg. Co., Ltd.
Neurology · 309d
Cleared Aug 22, 2002
XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT
K020226 · JWZ
Hellen Professional Services
Microbiology · 212d
Cleared Aug 22, 2002
ARTERIA BLOOD FILTER
K021293 · FPB
Arteria Medical Science, Inc.
General Hospital · 121d
Cleared Aug 22, 2002
CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION...
K022102 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 55d
Cleared Aug 22, 2002
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K022128 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 52d
Cleared Aug 22, 2002
SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
K022397 · LNH
GE Medical Systems
Radiology · 30d
Cleared Aug 22, 2002
DISPOSABLE PRESSURE MANOMETER
K022402 · CAP
Vital Signs, Inc.
Anesthesiology · 30d
Cleared Aug 22, 2002
CONTOUR SE MICROSPHERES
K022427 · HCG
Boston Scientific Corp
Neurology · 28d
Cleared Aug 22, 2002
S2 FEMORAL NAIL
K022461 · HSB
Howmedica Osteonics
Orthopedic · 27d
Cleared Aug 22, 2002
ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
K022480 · HIH
Acmi Corporation
Obstetrics & Gynecology · 27d
Cleared Aug 22, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438
K022707 · DIF
Bio-Rad
Chemistry · 8d
Cleared Aug 21, 2002
COSMOS SYSTEM
K013046 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 345d
Cleared Aug 21, 2002
SURE-LOK
K021315 · FMI
Vital Signs, Inc.
General Hospital · 118d
Cleared Aug 21, 2002
REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP
K021528 · JOW
Adven Medical
Cardiovascular · 103d
Cleared Aug 21, 2002
FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
K021972 · CDZ
Qualigen, Inc.
Chemistry · 65d
Cleared Aug 21, 2002
TRIONOMER
K022150 · EMA
Pentron Clinical Technologies
Dental · 50d
Cleared Aug 21, 2002
PTS PANELS MULTI-CHEMISTRY CONTROLS
K022401 · JJY
Polymer Technology Systems, Inc.
Chemistry · 29d
Cleared Aug 21, 2002
MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
K022453 · DSI
Welch Allyn Protocol, Inc.
Cardiovascular · 26d
Cleared Aug 21, 2002
DORNIER MEDILAS H LASER FIBER CABLES
K022544 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 20d
Cleared Aug 21, 2002
PERFUSOR COMPACT WITH FM SYSTEM
K022575 · FRN
B.Braun Medical, Inc.
General Hospital · 19d
Cleared Aug 21, 2002
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
K022603 · CEW
Diagnostic Products Corp.
Toxicology · 15d
Cleared Aug 21, 2002
BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
K022605 · KWQ
Blackstone Medical, Inc.
Orthopedic · 15d
Cleared Aug 20, 2002
GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
K012931 · FRG
Allegiance Healthcare Corp.
General Hospital · 354d
Cleared Aug 20, 2002
MSS-28CS-301/701 NEEDLESCOPE
K013759 · GWG
Olympus Optical Co., Ltd.
Neurology · 280d