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
93001–93024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1997
LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM
K971193 · GEX
Polytec Pi, Inc.
General & Plastic Surgery · 84d
Cleared Jun 24, 1997
ORTHOTEC K-CAP SYSTEM
K971453 · HTY
Orthotech
Orthopedic · 64d
Cleared Jun 24, 1997
DEGANIA SILICONE SIL-K
K971482 · MDA
Degania Silicone , Ltd.
General & Plastic Surgery · 64d
Cleared Jun 24, 1997
SECURE-WRAP (TM) STERILIZATION WRAP
K971483 · FRG
American Threshold Industries, Inc.
General Hospital · 62d
Cleared Jun 24, 1997
PLUSTRON ION TOOTHBRUSH SYSTEM
K971639 · MMD
Sas Group, Inc.
Dental · 53d
Cleared Jun 24, 1997
CEBE
K971644 · HQY
Suunto USA
Ophthalmic · 50d
Cleared Jun 24, 1997
IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM
K971685 · HKI
Tomey Corporation USA
Ophthalmic · 48d
Cleared Jun 24, 1997
SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR
K971711 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 47d
Cleared Jun 24, 1997
THYROTROPIN(TSH) ELISA
K971780 · JLW
Monobind
Chemistry · 41d
Cleared Jun 24, 1997
PERMALUTE, TRY-IN PASTE
K971898 · EBF
Ultradent Products, Inc.
Dental · 33d
Cleared Jun 24, 1997
CALCIUM REAGENT
K971907 · CIC
Carolina Liquid Chemistries Corp.
Chemistry · 32d
Cleared Jun 24, 1997
PROLACTIN (PRL) HORMONE MICROPLATE ELISA
K971921 · CFT
Monobind
Chemistry · 32d
Cleared Jun 24, 1997
SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR
K971987 · JEY
Synthes (Usa)
Dental · 26d
Cleared Jun 24, 1997
SUNGLASSES (NON-PRESCRIPTION)
K972014 · HQY
Tamfort, Ltd.
Ophthalmic · 25d
Cleared Jun 24, 1997
KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE
K972047 · MQN
KLS-Martin L.P.
Dental · 22d
Cleared Jun 24, 1997
TOTAL BILIRUBIN REAGENT
K972073 · CIG
Carolina Liquid Chemistries Corp.
Chemistry · 21d
Cleared Jun 24, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070),...
K972133 · JLS
Johnson & Johnson Clinical...
Chemistry · 18d
Cleared Jun 24, 1997
LYPHOCHEK REMEDI CONTROL
K972174 · DIF
Bio-Rad
Toxicology · 15d
Cleared Jun 24, 1997
RIVIERA SUNGLASS4ES
K972194 · HQY
Riviera Optical Co., Ltd.
Ophthalmic · 14d
Cleared Jun 24, 1997
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
K972214 · JJY
Roche Diagnostic Systems, Inc.
Chemistry · 12d
Cleared Jun 24, 1997
ABBOTT AXSYM FOLATE
K972232 · CGN
Abbott Laboratories
Chemistry · 8d
Cleared Jun 23, 1997
EDOSSEOUS DENTAL IMPLANT
K970127 · DZE
Sulzer Calcitek, Inc.
Dental · 160d
Cleared Jun 23, 1997
SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM
K970752 · DZE
Sulzer Calcitek, Inc.
Dental · 112d
Cleared Jun 23, 1997
ARTHROSCOPE
K971083 · HRX
Electro-Biology, Inc.
Orthopedic · 90d