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
104857–104880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1995
LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE)
K946155 · LYY
Mala Intertrade Co., Ltd.
General Hospital · 32d
Cleared Jan 17, 1995
CEDIA(R) FOLATE (NO BOIL) ASSAY
K946184 · CGN
Microgenics Corp.
Chemistry · 28d
Cleared Jan 17, 1995
EYE COOLER
K946231 · HQY
Direct Import Marketing Co.
Ophthalmic · 26d
Cleared Jan 17, 1995
SUNGLASSES
K946256 · HQY
Chanel, Inc.
Ophthalmic · 25d
Cleared Jan 13, 1995
ROAD WARRIOR
K935749 · ITI
Redman, Inc.
Physical Medicine · 413d
Cleared Jan 13, 1995
THE VANGUARD SYSTEM
K941551 · GWQ
Cleveland Clinic Foundation
Neurology · 289d
Cleared Jan 13, 1995
HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR
K945040 · GZT
Hamid M. Mehdizadeh, M.D.
Neurology · 91d
Cleared Jan 13, 1995
VERSASAE PLASTIC CANNULA- 11 GAUGE
K945070 · FPA
Imed Corp.
General Hospital · 91d
Cleared Jan 13, 1995
KOLBERG OPHTHALMIC CONFORMER
K945110 · HQN
Kolberg Ocular Products, Inc.
Ophthalmic · 87d
Cleared Jan 13, 1995
EXPIRATORY BREATHING EXERCISER
K945118 · BWF
Dhd Diemolding Healthcare Div.
Anesthesiology · 87d
Cleared Jan 13, 1995
BA-CPAS
K945154 · FZE
Nobelpharma USA, Inc.
General & Plastic Surgery · 84d
Cleared Jan 13, 1995
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
K945513 · JOH
Mallinckrodt Medical
Anesthesiology · 65d
Cleared Jan 13, 1995
SPIRO-FLEX
K945565 · CAI
Inhalation Plastics
Anesthesiology · 119d
Cleared Jan 13, 1995
SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER
K945593 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 60d
Cleared Jan 13, 1995
QUICK-LOCK
K945816 · BTR
B&B Medical Technologies, Inc.
Anesthesiology · 46d
Cleared Jan 12, 1995
LATERAL FLEXION MACHINE
K940455 · BXB
Rehab, Inc.
Physical Medicine · 345d
Cleared Jan 12, 1995
PRO-TECT TRAUMA PAK
K941789 · MGP
Pro-Tect Medical Products, Inc.
General & Plastic Surgery · 276d
Cleared Jan 12, 1995
PRO-TECT SAFETY DRESSING
K941790 · MGP
Pro-Tect Medical Products, Inc.
General & Plastic Surgery · 276d
Cleared Jan 12, 1995
APILUS ELECTROPIL
K943928 · KCW
Dectro Intl., Inc.
General & Plastic Surgery · 153d
Cleared Jan 12, 1995
HEINE LAMBDA 100
K944156 · HOX
Heine USA , Ltd.
Ophthalmic · 139d
Cleared Jan 12, 1995
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
K944601 · LZO
Zimmer, Inc.
Orthopedic · 115d
Cleared Jan 12, 1995
IRRIGATION TRAY
K944882 · EYN
Clinical Resources, Inc.
General & Plastic Surgery · 101d
Cleared Jan 12, 1995
SPONGE COUNT
K945144 · LWH
Michael Fischer Assoc.
General & Plastic Surgery · 84d
Cleared Jan 12, 1995
HAIR REMOVAL SYSTEM
K945192 · KCW
L.P. Systems Corp.
General & Plastic Surgery · 80d