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
79249–79272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 2001
LOCALISA CARDIAC NAVIGATION SYSTEM
K002869 · DQK
Medtronic Surgical Navigation...
Cardiovascular · 195d
Cleared Mar 27, 2001
KSEA SCB-RUI SCO
K003113 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 174d
Cleared Mar 27, 2001
3M LITTMANN
K003723 · DQD
3M Company
Cardiovascular · 113d
Cleared Mar 27, 2001
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
K004011 · DSY
Impra, Inc.
Cardiovascular · 90d
Cleared Mar 27, 2001
SHEER THIN AROMAS BLUE LATEX CONDOM
K004016 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 27, 2001
F1 DIODE LASER SYSTEM
K004021 · GEX
Opus Medical, Inc.
General & Plastic Surgery · 90d
Cleared Mar 27, 2001
ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING
K004028 · FRO
Maersk Medical, Ltd.
General & Plastic Surgery · 90d
Cleared Mar 27, 2001
SHEER THIN AROMAS GREEN LATEX CONDOM
K004036 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 89d
Cleared Mar 27, 2001
WILLI GELLER CREAPEARL
K010160 · ELM
Jensen Industries, Inc.
Dental · 70d
Cleared Mar 27, 2001
CALEX CONDITIONER
K010176 · EJK
Stephen M Koral, Dmd
Dental · 68d
Cleared Mar 27, 2001
POLYCARBOXYLATE (PCA) CEMENT
K010240 · EMA
Rite-Dent Manufacturing Corp.
Dental · 61d
Cleared Mar 27, 2001
LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE
K010347 · LYY
Enzymic Technologies Sdn Bhd
General Hospital · 50d
Cleared Mar 27, 2001
LATEX EXAMINATION GLOVES-POWDER FREE
K010356 · LYY
Enzymic Technologies Sdn Bhd
General Hospital · 50d
Cleared Mar 27, 2001
R & D DESIGNATION AP-035
K010414 · EJT
Jensen Industries, Inc.
Dental · 43d
Cleared Mar 27, 2001
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
K010568 · KNS
Arthrocare Corp.
Gastroenterology & Urology · 29d
Cleared Mar 27, 2001
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · ODC
Boston Scientific Corp
Gastroenterology & Urology · 26d
Cleared Mar 27, 2001
R & D DESIGNATION AP-047
K010611 · EJT
Jensen Industries, Inc.
Dental · 26d
Cleared Mar 26, 2001
PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE
K000655 · IRP
Ahava Stein
Physical Medicine · 392d
Cleared Mar 26, 2001
FOGARTY VALVULOTOME, MODEL 700091
K001734 · MGZ
Edwards Lifesciences, LLC
Cardiovascular · 292d
Cleared Mar 26, 2001
DJ ORTHOPEDICS FEMORAL ANCHOR
K002829 · MBI
Dj Orthopedics, LLC
Orthopedic · 196d
Cleared Mar 26, 2001
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
K003345 · LPN
Ciba Vision Corporation
Ophthalmic · 152d
Cleared Mar 26, 2001
DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)
K003993 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 90d
Cleared Mar 26, 2001
SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER
K004006 · GEX
Lumenis, Inc.
General & Plastic Surgery · 90d
Cleared Mar 26, 2001
LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100
K010013 · GEI
Valleylab, Inc.
General & Plastic Surgery · 83d