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
90481–90504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 29, 1998
TTM5000 TELEPHONIC EKG MONITOR
K973267 · DXH
Hds Medical, Inc.
Cardiovascular · 153d
Cleared Jan 29, 1998
EASYSAFE RETRACTING NEEDLE SYRINGE
K973792 · MEG
Saf-T-Med, Inc.
General Hospital · 115d
Cleared Jan 29, 1998
SAFEPASS STERILIZATION POUCH
K973981 · KCT
Adroit Medical Systems, Inc.
General Hospital · 101d
Cleared Jan 29, 1998
VACUDAP, MODEL 2000, 2001
K974112 · KPR
Victoreen, Inc.
Radiology · 90d
Cleared Jan 29, 1998
LUBRICATED BAGGY TACTYLON CONDOM
K974121 · MOL
Sensicon Corp.
Obstetrics & Gynecology · 90d
Cleared Jan 29, 1998
VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE
K974130 · LMD
Dejarnette Research Systems
Radiology · 87d
Cleared Jan 29, 1998
POSITION PENTA, POSITION PENTA QUICK
K974231 · ELW
Espe GmbH & Co. Kg.
Dental · 78d
Cleared Jan 29, 1998
VITALESCENCE
K974282 · EBF
Ultradent Products, Inc.
Dental · 76d
Cleared Jan 29, 1998
PQ 1
K974283 · KLE
Ultradent Products, Inc.
Dental · 76d