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
109009–109032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1994
SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS
K934581 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 189d
Cleared Mar 31, 1994
CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS
K935170 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 155d
Cleared Mar 31, 1994
ERBOTOM ICC 50
K935815 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 119d
Cleared Mar 31, 1994
OMNI WARM GEL PACKS
K936084 · IMD
Omni Therm, Inc.
Physical Medicine · 100d
Cleared Mar 31, 1994
VIDEO CAMERAS, ENCOSCOPIC AND SURGICAL
K936097 · GCJ
Micromedical Devices, Inc.
General & Plastic Surgery · 99d
Cleared Mar 31, 1994
UNIPOWER RECHARGEABLE BATTERY PACK
K936141 · BXP
Unipower Corp.
Anesthesiology · 94d
Cleared Mar 31, 1994
CUSTOM CV PACK
K936255 · KDD
Associated Medical
General & Plastic Surgery · 91d
Cleared Mar 31, 1994
ENDEX ENDOSCOPIC POSITIONING SYSTEM
K936308 · FQO
Andronic Devices, Ltd.
General & Plastic Surgery · 101d
Cleared Mar 31, 1994
WET DRESSING
K940691 · FRO
Medtrax Industries, Inc.
General & Plastic Surgery · 43d
Cleared Mar 31, 1994
SYSTEM 1
K940845 · DYH
Sybron Dental Specialties, Inc.
Dental · 36d
Cleared Mar 31, 1994
AURIUM D17 (HIGH GOLD CROWN & BRIDGE ALLOY)
K940865 · EJT
Argen Precious Metals, Inc.
Dental · 36d
Cleared Mar 31, 1994
NON-WOVEN SPONGE
K940901 · EFQ
Medical Insights, Inc.
General & Plastic Surgery · 35d
Cleared Mar 31, 1994
AURIUM 50Y
K940929 · EJT
Argen Precious Metals, Inc.
Dental · 31d
Cleared Mar 31, 1994
AURIUM X6 (MEDIUM GOLD CROWN AND BRIDGE ALLOY)
K941002 · EJT
Argen Precious Metals, Inc.
Dental · 30d
Cleared Mar 31, 1994
AURIUM 20% (LOW GOLD CROWN AND BRIDGE ALLOY)
K941003 · EJT
Argen Precious Metals, Inc.
Dental · 30d
Cleared Mar 31, 1994
ORMCO SYSTEM 1+ (TM)
K941015 · DYH
Ormco Corp.
Dental · 28d
Cleared Mar 30, 1994
ENDOMED LAPAROSCOPY INSTRUMENTS
K921686 · KNF
Buckman Co., Inc.
Obstetrics & Gynecology · 721d
Cleared Mar 30, 1994
GRANULYTE DIALYSATE CONCENTRATE
K922005 · KPO
Fresenius USA, Inc.
Gastroenterology & Urology · 700d
Cleared Mar 30, 1994
KINAMED REALITY TOTAL HIP SYSTEM
K922247 · LZO
Kinamed, Inc.
Orthopedic · 686d
Cleared Mar 30, 1994
PACE SAVER LITTLE JR
K925122 · INI
Burke Mobility Products
Physical Medicine · 537d
Cleared Mar 30, 1994
CD HOME DIALYSERVICE HEMODIALYSIS TRAY
K925654 · KOC
Cd Medical, Inc.
Gastroenterology & Urology · 506d
Cleared Mar 30, 1994
AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER
K925907 · ISA
Pollenex Corp.
Physical Medicine · 495d
Cleared Mar 30, 1994
CARD GUARD MODEL CG-8000
K926515 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 455d
Cleared Mar 30, 1994
ASSESS(TM) LOW ABNORMAL CONTROL
K931117 · GJS
Instrumentation Laboratory CO
Hematology · 391d