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
90985–91008 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1998
ROCKET ELECTRODE
K974138 · HGI
A & A Medical, Inc.
Obstetrics & Gynecology · 88d
Cleared Jan 30, 1998
3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M...
K974279 · GEI
3M Healthcare
General & Plastic Surgery · 77d
Cleared Jan 30, 1998
INFANT FLOW SYSTEM
K974303 · BZD
Sensor Medics Corp.
Anesthesiology · 74d
Cleared Jan 30, 1998
LACTOSORB PANELS
K974309 · HRS
Biomet, Inc.
Orthopedic · 74d
Cleared Jan 30, 1998
ADVANCE TOTAL KNEE SYSTEM
K974328 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 73d
Cleared Jan 30, 1998
KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM
K974391 · GCJ
Karl Storz Imaging, Inc.
General & Plastic Surgery · 70d
Cleared Jan 30, 1998
LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM
K974392 · DZL
Biovision GmbH
Dental · 70d
Cleared Jan 30, 1998
IBI
K974440 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 66d
Cleared Jan 30, 1998
COMPOGLASS FLOW
K974577 · EBF
Ivoclar North America, Inc.
Dental · 53d
Cleared Jan 30, 1998
VINYL EXAMINATION GLOVES POWDER FREE
K974777 · LYZ
Sun Flower Gloves Co., Ltd.
General Hospital · 39d
Cleared Jan 30, 1998
BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS
K974825 · JIX
Boehringer Mannheim Corp.
Chemistry · 37d
Cleared Jan 30, 1998
NON-PRESCRIPTION SUNGLASSES
K974852 · HQY
Chia Hui Spectacles Mfg. Corp.
Ophthalmic · 32d
Cleared Jan 30, 1998
PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30
K974858 · CEO
Diagnostic Chemicals , Ltd.
Chemistry · 32d
Cleared Jan 30, 1998
NON-PRESCRIPTION SUNGLASSES
K974860 · HQY
Wenzhou Ming Ming Optical Co. , Ltd.
Ophthalmic · 32d
Cleared Jan 30, 1998
POWDERED GREEN NITRILE EXAMINATION GLOVES
K974886 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 31d
Cleared Jan 30, 1998
MANAN D BAG
K980005 · EXF
Medical Device Technologies, Inc.
Gastroenterology & Urology · 28d
Cleared Jan 30, 1998
AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION...
K980030 · CIT
Trace America, Inc.
Chemistry · 25d
Cleared Jan 30, 1998
MANAN SOFT TISSUE BIOPSY NEEDLES
K980122 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 16d
Cleared Jan 30, 1998
WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY
K980137 · LRO
Worldwide Medical Technologies, LLC
General & Plastic Surgery · 15d
Cleared Jan 29, 1998
BROWNE MVI STEAM INDICATOR
K971369 · JOJ
Albert Browne , Ltd.
General Hospital · 290d
Cleared Jan 29, 1998
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER
K971670 · DSH
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 268d
Cleared Jan 29, 1998
SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL
K972935 · EMA
S.S. White Mfg., Ltd.
Dental · 174d
Cleared Jan 29, 1998
NORLAND MODEL PDEXA BONE DENSITOMETER
K973104 · KGI
Norland Corp.
Radiology · 163d
Cleared Jan 29, 1998
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR
K973106 · BTM
Allied Healthcare Products, Inc.
Anesthesiology · 163d