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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
124897–124920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1990
CANCELLOUS SCREW
K903253 · HWC
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
U.S. TYPE CRUCIATE SLOT BONE SCREW
K903254 · HWC
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
CORTICAL BONE SCREW (EUROPEAN STYLE)
K903255 · HWC
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
HAGIE PIN
K903258 · HWC
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
KNOWLES PIN
K903259 · HWC
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE
K903419 · GDH
United States Surgical, A Division of...
General & Plastic Surgery · 9d
Cleared Aug 08, 1990
QSI 9000
K894560 · GWF
Quantified Signal Imaging, Inc.
Neurology · 384d
Cleared Aug 08, 1990
CADD-PCA AMBULATORY INFUSION PUMPS
K895644 · FRN
Pharmacia Deltec, Inc.
General Hospital · 322d
Cleared Aug 08, 1990
BIOTRONIK'S PS-ENDOCARDIAL LEADS
K896824 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 247d
Cleared Aug 08, 1990
LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING
K900645 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 180d
Cleared Aug 08, 1990
ITC INTRODUCER CATHETER
K900756 · DYB
Interventional Therapeutics Corp.
Cardiovascular · 173d
Cleared Aug 08, 1990
HAFCON (FLOURO FOOTSWITCH)
K901671 · JAA
B & H Research Instruments
Radiology · 120d
Cleared Aug 08, 1990
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · KGX
3M Company
General & Plastic Surgery · 113d
Cleared Aug 08, 1990
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH.
K901791 · KGC
Southside Biotechnology
Gastroenterology & Urology · 111d
Cleared Aug 08, 1990
GASTROSTOMY FEEDING CATHETER
K901795 · KGC
Southside Biotechnology
Gastroenterology & Urology · 111d
Cleared Aug 08, 1990
OHMEDA - LOGIC 07A TRANSPORT VENTILATOR
K901846 · BTL
Ohmeda Medical
Anesthesiology · 106d
Cleared Aug 08, 1990
MODIFIED SEPACELL R-SERIES BLOOD FILTERS
K901887 · CAK
Asahi Medical Co., Ltd.
General Hospital · 104d
Cleared Aug 08, 1990
MAGIC HOT SHADES 70116, 70118, 70119
K902033 · HQY
Nationmark, Inc.
Ophthalmic · 96d
Cleared Aug 08, 1990
MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND
K902088 · DPW
Hewlett-Packard Co.
Cardiovascular · 90d
Cleared Aug 08, 1990
POLARON
K902187 · HPG
Nurion Industries
Ophthalmic · 86d
Cleared Aug 08, 1990
ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE
K902207 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 84d
Cleared Aug 08, 1990
MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE
K902221 · DXT
Mallinckrodt Group, Inc.
Cardiovascular · 83d
Cleared Aug 08, 1990
VISION JANTZEN SUNGLASSES
K902415 · HQY
Vision Products Co., Inc.
Ophthalmic · 69d
Cleared Aug 08, 1990
R.P.I. GRAVITY SAFE FEEDING BAG
K902729 · KNT
Ridge Products, Inc.
Gastroenterology & Urology · 48d