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
122041–122064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1991
GAUZE SPONGES ABSORBENT GAUZE ROLLS
K910623 · EFQ
Liaoning-Usa Corp.
General & Plastic Surgery · 47d
Cleared Apr 01, 1991
WEEVAC TC HAND CARRIED RESCUE STRETCHER
K910709 · FPP
W. Murphy Ent., Inc.
General Hospital · 40d
Cleared Apr 01, 1991
CLEANFLOW SYSTEM
K910728 · KQT
Mitron Technologies, Inc.
Gastroenterology & Urology · 40d
Cleared Apr 01, 1991
EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS
K910863 · DSY
Vascutek, Ltd.
Cardiovascular · 31d
Cleared Apr 01, 1991
EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS
K910864 · DSY
Vascutek, Ltd.
Cardiovascular · 31d
Cleared Apr 01, 1991
TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS
K910865 · DSY
Vascutek, Ltd.
Cardiovascular · 31d
Cleared Apr 01, 1991
VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS
K910866 · DSY
Vascutek, Ltd.
Cardiovascular · 31d
Cleared Apr 01, 1991
PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X
K910897 · GDW
3M Medical Products Group
General & Plastic Surgery · 28d
Cleared Apr 01, 1991
CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS
K910906 · FPK
Tri-State Hospital Supply Corp.
General Hospital · 27d
Cleared Apr 01, 1991
CLEARVIEW HCG
K910946 · JHJ
Unipath , Ltd.
Chemistry · 26d
Cleared Apr 01, 1991
TEKDYNE MICRO RETRACTOR
K910975 · GAD
Tekdyne
General & Plastic Surgery · 25d
Cleared Mar 29, 1991
TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.
K902305 · HIS
Armkel, LLC
Obstetrics & Gynecology · 311d
Cleared Mar 29, 1991
TP AND DESIGN, CONDOM
K902324 · HIS
China National Medicines & Health...
Obstetrics & Gynecology · 309d
Cleared Mar 29, 1991
RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL
K903011 · BZQ
Non-Invasive Monitoring Systems, Inc.
Anesthesiology · 263d
Cleared Mar 29, 1991
O BUTMENT
K903211 · DZE
"O" Co., Inc.
Dental · 252d
Cleared Mar 29, 1991
C544 TRANSDUCER
K904459 · ITX
Acuson Corp.
Radiology · 179d
Cleared Mar 29, 1991
BC 1219 HEALING HEAD
K904710 · DZE
Minimatic Implant Technology
Dental · 164d
Cleared Mar 29, 1991
BC 1221 BALL OVERDENTURE ATTACHMENT
K904712 · DZE
Minimatic Implant Technology
Dental · 164d
Cleared Mar 29, 1991
TENTATIVE OPERATING NAME-JAZZ BAND
K904805 · EBF
Franklin M. Din D.M.D., P.A.
Dental · 157d
Cleared Mar 29, 1991
ORIGINEEDLE(TM)
K904849 · FHO
Origin Medsystems, Inc.
Gastroenterology & Urology · 154d
Cleared Mar 29, 1991
SINGLE USE MANUAL RESUSCITATORS
K905002 · BTM
Custom Medical, Inc.
Anesthesiology · 142d
Cleared Mar 29, 1991
DW 236
K905204 · EJJ
Ivoclar North America, Inc.
Dental · 129d
Cleared Mar 29, 1991
FLOWIRE AND FLOMAP
K905411 · DPW
Cardio Metrics, Inc.
Cardiovascular · 116d
Cleared Mar 29, 1991
NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR
K905481 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 113d