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
92593–92616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1997
ELECSYS PSA ASSAY
K964351 · LTJ
Boehringer Mannheim Corp.
Immunology · 266d
Cleared Jul 25, 1997
PERCUTANEOUS VENOUS INTRODUCER 10264
K965167 · DYB
Medamicus, Inc.
Cardiovascular · 213d
Cleared Jul 25, 1997
ARROW-TREROTOLA PTD CATHETER
K970080 · MCW
Arrow Intl., Inc.
Cardiovascular · 197d
Cleared Jul 25, 1997
ANNULOFLO SYSTEM
K970375 · KRH
Carbomedics, Inc.
Cardiovascular · 172d
Cleared Jul 25, 1997
VIBRA-SURGE SYSTEM MODEL VS2120
K971533 · LFL
Sonics & Materials, Inc.
General & Plastic Surgery · 88d
Cleared Jul 25, 1997
PROTEGE LIQUID OXYGEN SYSTEM
K971545 · BYJ
Healthdyne Technologies, Inc.
Anesthesiology · 88d
Cleared Jul 25, 1997
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND...
K971660 · FDS
Olympus America, Inc.
Radiology · 80d
Cleared Jul 25, 1997
RAMY PISTON SYRINGE
K971664 · FMF
Alshifa Medical Syringes Mfg. Co., Ltd.
General Hospital · 80d
Cleared Jul 25, 1997
IMMULITE FREE T4 (2-STEP)
K971792 · CEC
Diagnostic Products Corp.
Chemistry · 71d
Cleared Jul 25, 1997
SUCTION INSTRUMENTATION
K972074 · GCX
Walter Lorenz Surgical, Inc.
General Hospital · 52d
Cleared Jul 25, 1997
VON WILLEBRAND REAGENT
K972116 · GGP
Behring Diagnostics, Inc.
Hematology · 50d
Cleared Jul 25, 1997
PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905
K972123 · FMQ
Smith
General Hospital · 50d
Cleared Jul 25, 1997
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
K972144 · JBQ
Sigma Diagnostics, Inc.
Hematology · 49d
Cleared Jul 25, 1997
POCKET COUNT OR SAFETCOUNT
K972302 · LWH
Sage Products, Inc.
General & Plastic Surgery · 36d
Cleared Jul 25, 1997
CARDIAC STATUS CONTROLS
K972408 · JJT
Spectral Diagnostics, Inc.
Chemistry · 29d
Cleared Jul 25, 1997
D'ARC EYE CARE SUNGLASSES
K972490 · HQY
M & R Dist.
Ophthalmic · 23d
Cleared Jul 24, 1997
CORELIFE
K964230 · FMF
Core Healthcare , Ltd.
General Hospital · 274d
Cleared Jul 24, 1997
COLORMATE III
K964590 · MQM
Chromatics Color Sciences Intl., Inc.
Chemistry · 251d
Cleared Jul 24, 1997
CYBERREN
K970989 · KPF
Cybernius Medical , Ltd.
Gastroenterology & Urology · 128d
Cleared Jul 24, 1997
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT
K971180 · KDI
C.R. Bard, Inc.
Gastroenterology & Urology · 115d
Cleared Jul 24, 1997
RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE
K971511 · JXG
Radionics, Inc.
Neurology · 87d
Cleared Jul 24, 1997
AMS COAGULOOP RESECTION ELECTRODE
K971512 · FAS
American Medical Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 24, 1997
KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES
K971518 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared Jul 24, 1997
REACH ANTIBACTERIAL TOOTHBRUSH
K971589 · EFW
Personal Products Co.
Dental · 84d