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
77953–77976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2001
WUJIN #3 TIBIAL BONE PLATE
K011460 · HRS
Biopro, Inc.
Orthopedic · 88d
Cleared Aug 07, 2001
PRAXSYS RELIA TSH TEST
K011527 · JLW
Praxsys Biosystems, Inc.
Chemistry · 82d
Cleared Aug 07, 2001
COLLAGEN DENTAL MEMBRANE
K011695 · NPL
Collagen Matrix, Inc.
Dental · 68d
Cleared Aug 07, 2001
SCS CLARIS SPINAL SCREWS, TYPES V,G,E
K011807 · MNI
Ortho Tec, LLC
Orthopedic · 57d
Cleared Aug 07, 2001
PIT AND FISSURE CHEMICAL CURING SEALANT
K011822 · EBC
Rite-Dent Manufacturing Corp.
Dental · 57d
Cleared Aug 07, 2001
GC E-LIGHT
K012134 · EBZ
GC America, Inc.
Dental · 29d
Cleared Aug 07, 2001
QUIK-CHECK HOME PREGNANCY TEST
K012215 · LCX
ACON Laboratories, Inc.
Chemistry · 22d
Cleared Aug 07, 2001
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
K012287 · MRR
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Aug 07, 2001
CT COLONOGRAPHY/NAVIGATOR2
K012313 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Aug 06, 2001
ADD-ON CONDYLE
K002790 · NEI
Walter Lorenz Surgical, Inc.
Dental · 333d
Cleared Aug 06, 2001
CONDUCTIVE GEL FOR ULTRASOUND
K002832 · GYB
Skylark Device & Systems Co., Ltd.
Neurology · 329d
Cleared Aug 06, 2001
CROSS-CHECKS DUAL, MODEL CI 125
K010534 · JOJ
Steritec Products, Inc.
General Hospital · 164d
Cleared Aug 06, 2001
MUSCLE IMAGING SYSTEM (MIS)
K011416 · LNH
Millennium Magnetic Imaging, Inc.
Radiology · 90d
Cleared Aug 06, 2001
CHILLIT
K011666 · EAT
Heatshield, Inc.
Dental · 68d
Cleared Aug 06, 2001
FLEXICAST PRIME
K011706 · EJH
American Dent-All, Inc.
Dental · 63d
Cleared Aug 06, 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
K011751 · INI
Merits Health Products., Inc.
Physical Medicine · 61d
Cleared Aug 06, 2001
STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K012282 · LYZ
Cypress Medical Products, Ltd.
General Hospital · 17d
Cleared Aug 06, 2001
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER...
K981693 · LFD
Gebauer Co.
Dental · 1181d
Cleared Aug 06, 2001
DISPO ETCH
K984380 · KOJ
Kis Products
Dental · 972d
Cleared Aug 06, 2001
DISPODRILL
K993124 · KOJ
Kis Products
Dental · 686d
Cleared Aug 06, 2001
DISPOPROPHY
K993182 · KOJ
Kis Products
Dental · 683d
Cleared Aug 03, 2001
MICROSTIM 100I TENS DEVICE
K010295 · GZJ
Microstim, Inc.
Neurology · 184d
Cleared Aug 03, 2001
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
K010345 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 179d
Cleared Aug 03, 2001
GEO STRUCTURE
K010530 · MQP
Interpore Cross Intl.
Orthopedic · 161d