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
104089–104112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1995
CHILDREN'S SUNGLASSES
K950226 · HQY
Consolidated Stores Corp.
Ophthalmic · 50d
Cleared Mar 01, 1995
BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST
K950307 · DHA
Princeton BioMeditech Corp.
Chemistry · 35d
Cleared Mar 01, 1995
NON-PRESCRIPTION SUNGLASSES
K950391 · HQY
Aceway Sunglasses Corp.
Ophthalmic · 28d
Cleared Mar 01, 1995
SURGICAL BUR
K950449 · GFF
Transidyne General Corp.
General & Plastic Surgery · 26d
Cleared Mar 01, 1995
MARTIN SUNGLASSES
K950456 · HQY
Jack Martin Co., Inc.
Ophthalmic · 26d
Cleared Mar 01, 1995
CANDELA SHEATH SETS
K950634 · DQY
Candela Laser Corp.
Cardiovascular · 16d
Cleared Mar 01, 1995
CANDEKA DUKATIR SETS
K950635 · DQY
Candela Laser Corp.
Cardiovascular · 16d
Cleared Mar 01, 1995
KBTC
K950720 · HQY
Kyong-Buk Trading Corp.
Ophthalmic · 37d
Cleared Feb 28, 1995
CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020
K932276 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 657d
Cleared Feb 28, 1995
CERVEX-BRUSH PAP KIT
K941472 · HHT
Rovers Diagnostic Devices
Obstetrics & Gynecology · 337d
Cleared Feb 28, 1995
DISPOSABLE LATEX EXAM GLOVES
K941557 · LYY
Dah Lee Investments, Ltd.
General Hospital · 334d
Cleared Feb 28, 1995
KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE
K942112 · FBN
Karl Storz Endoscopy
Gastroenterology & Urology · 302d
Cleared Feb 28, 1995
TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER
K942918 · OCX
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 252d
Cleared Feb 28, 1995
BILIARY STENT
K943143 · FGE
Menlo Care, Inc.
Gastroenterology & Urology · 243d
Cleared Feb 28, 1995
CLEAN AIR
K943201 · GEX
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 238d
Cleared Feb 28, 1995
RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM
K944069 · DZE
Lifecore Biomedical, Inc.
Dental · 194d
Cleared Feb 28, 1995
OREX SURGEON'S GOWN
K944827 · FYA
Thantex Specialties, Inc.
General Hospital · 152d
Cleared Feb 28, 1995
OREX SURGICAL DRAPES
K944859 · KKX
Thantex Specialties, Inc.
General Hospital · 148d
Cleared Feb 28, 1995
COMPEL SURGICALDRAPES
K944863 · KKX
Standard Textile Co., Inc.
General Hospital · 148d
Cleared Feb 28, 1995
BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM
K944964 · DZE
Nobelpharma USA, Inc.
Dental · 144d
Cleared Feb 28, 1995
OP-D-OP II
K945098 · LYU
Op-D-Op Visor Shields, Inc.
General Hospital · 133d
Cleared Feb 28, 1995
RENAGUARD DIALYSATE FILTER
K945136 · FIP
Minntech Corp.
Gastroenterology & Urology · 131d
Cleared Feb 28, 1995
SPLATTER CONTROL SHIELD
K945486 · KKX
Taut, Inc.
General Hospital · 112d
Cleared Feb 28, 1995
TROCAR AND CANNULA ACCESSORY
K945741 · HET
Applied Medical Resources
Obstetrics & Gynecology · 97d