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
108913–108936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1994
DENTACOLOR VITA (VS) SHADE SYSTEM
K940800 · EBF
Heraeus Kulzer, Inc.
Dental · 44d
Cleared Apr 07, 1994
BASIC RECLINE CHAIR
K941157 · IOR
Labac Systems, Inc.
Physical Medicine · 27d
Cleared Apr 06, 1994
PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY
K920302 · LSK
Gen-Probe, Inc.
Microbiology · 806d
Cleared Apr 06, 1994
PHACO NEEDLES 1000-R & 1000-O NEEDLES
K923630 · HQC
O.R. Specialties, Inc.
Ophthalmic · 624d
Cleared Apr 06, 1994
AMYLASE
K930678 · JFJ
Horizon Diagnostics, Inc.
Chemistry · 421d
Cleared Apr 06, 1994
DAELIM CORP. EYE WEAR MODEL
K932612 · HQZ
Daelim Corp.
Ophthalmic · 313d
Cleared Apr 06, 1994
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K933572 · DOE
Immunalysis Corporation
Toxicology · 257d
Cleared Apr 06, 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
K934135 · KXT
Syva Co.
Toxicology · 224d
Cleared Apr 06, 1994
NON-PRESCRIPTION SUNGLASSES
K934461 · HQY
Good Bond Industrial Corp.
Ophthalmic · 208d
Cleared Apr 06, 1994
EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR
K934592 · JJG
Abaxis, Inc.
Chemistry · 194d
Cleared Apr 06, 1994
URINARY/CEREBROSPINAL FLUID PROTEIN
K934841 · CEK
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 180d
Cleared Apr 06, 1994
MTI PHOTOSCREENER
K934880 · MMF
Medical Technology and Innovations, Inc.
Ophthalmic · 176d
Cleared Apr 06, 1994
THE SIGNATURE SERIES, MAGNUM 100
K934919 · IPF
Progressive Electrical Therapeutics
Physical Medicine · 174d
Cleared Apr 06, 1994
RADIAS 3RD GENERATION TSH IMMUNOASSAY
K935119 · JLW
Bio-Rad
Chemistry · 161d
Cleared Apr 06, 1994
JIN CHANG SUNGLASSES
K935700 · HQY
Jin Chang Enterprise Co., Ltd.
Ophthalmic · 127d
Cleared Apr 06, 1994
SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR...
K935723 · LYU
Cabot Safety Corp.
General Hospital · 133d
Cleared Apr 06, 1994
SUNGLASSES
K935734 · HQY
Esparkle International Co., Ltd.
Ophthalmic · 126d
Cleared Apr 06, 1994
CEDIA DAU THC CALIBRATORS
K935795 · DLJ
Microgenics Corp.
Toxicology · 120d
Cleared Apr 06, 1994
SPECTACLE FRAMES
K935845 · HQZ
New Star Corp.
Ophthalmic · 119d
Cleared Apr 06, 1994
SPECTACLE FRAMES AND SUNGLASSES
K935974 · HQY
Pan Oceanic Eyewear
Ophthalmic · 114d
Cleared Apr 06, 1994
ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES
K936198 · GCT
Carl Zeiss, Inc.
Gastroenterology & Urology · 98d
Cleared Apr 06, 1994
SPECTACLE FRAME
K940326 · HQZ
D'Tochi, Inc.
Ophthalmic · 72d
Cleared Apr 06, 1994
SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP
K940371 · KYZ
Micromedics, Inc.
General Hospital · 90d
Cleared Apr 06, 1994
TALKING RAP SHADES
K940420 · HQY
Hilco Corp.
Ophthalmic · 68d