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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
74161–74184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 20, 2002
LASER FIBER GF500
K021686 · GEX
W.O.M. World of Medicine AG
General & Plastic Surgery · 90d
Cleared Aug 20, 2002
20G SMA LASER FIBER, MODEL LF20
K021696 · GEX
Ophthalmed, LLC
General & Plastic Surgery · 90d
Cleared Aug 20, 2002
ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
K021717 · GCT
World of Medicine Lemke GmbH
Gastroenterology & Urology · 89d
Cleared Aug 20, 2002
VASCLIP
K021745 · NJC
Vmbc, LLC
General & Plastic Surgery · 84d
Cleared Aug 20, 2002
FLASH-LITE LED DENTAL CURING LIGHT
K022184 · EBZ
Discus Dental, Inc.
Dental · 48d
Cleared Aug 20, 2002
SAPH-LOOP LIGATING LOOP
K022410 · GAT
Genzyme Biosurgery
General & Plastic Surgery · 27d
Cleared Aug 20, 2002
PHILIPS BABY THERMOMETER SET (SBC SC530)
K022542 · FLL
Philips Consumer Electronics
General Hospital · 19d
Cleared Aug 20, 2002
CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING,...
K022553 · GWM
Integra Neurosciences
Neurology · 18d
Cleared Aug 19, 2002
INDUS TEXTILES TOWEL-STERILE AND NON-STERILE
K013958 · KKX
Indus Textiles, Inc.
General Hospital · 262d