FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93505–93528 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1997
MASTER NEB II
K970542 · CAF
Bremed Italia, S.R.L.
Anesthesiology · 132d
Cleared Jun 24, 1997
QUANTA LITE B2GPI IGG
K970551 · MSV
Inova Diagnostics, Inc.
Immunology · 132d
Cleared Jun 24, 1997
SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
K970612 · DBF
Sealite Sciences, Inc.
Immunology · 126d
Cleared Jun 24, 1997
CLAVE CONNECTOR
K970855 · FPA
Icu Medical, Inc.
General Hospital · 106d
Cleared Jun 24, 1997
ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
K970882 · MPA
American Medical Devices, Inc.
Ophthalmic · 106d
Cleared Jun 24, 1997
BROWNE STEAM INDICATOR
K970918 · JOJ
Board of Directors, Albert Browne , Ltd.
General Hospital · 104d
Cleared Jun 24, 1997
HYDROCOLLOID WOUND DRESSINGS
K971126 · FRO
Innovative Technologies , Ltd.
General & Plastic Surgery · 89d
Cleared Jun 24, 1997
OXYPURE PORTABLE OXYGEN GENERATOR
K971129 · CAW
Arbor Research Corp.
Anesthesiology · 89d
Cleared Jun 24, 1997
SURGICAL DRAPES
K971159 · KKX
International Medsurg Connection
General Hospital · 85d
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