FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
109081–109104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 1994
DAVOL LAPAROSCOPIC INSUFFLATION NEEDLE FOR GENERAL LAPAROSCOPIC PROCEDURES
K936102 · GCJ
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 146d
Cleared May 17, 1994
SHARPLAN MODEL 1120 CO2 SURGICAL LASER
K936109 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 141d
Cleared May 17, 1994
HY-TEC TOTAL IGE ENZYME IMMUNOASSAY
K940183 · DGC
Hycor Biomedical, Inc.
Immunology · 125d
Cleared May 17, 1994
SUNGLASSES AND SPORT SUNGLASSES
K940311 · HQY
Lanner Enterprise Co., Ltd.
Ophthalmic · 113d
Cleared May 17, 1994
SPECTACLE FRAMES
K940504 · HQZ
Tecnol-Tecnica Nacional DE Oculos Ltda
Ophthalmic · 103d
Cleared May 17, 1994
TOUCH CORP
K940609 · HQY
Touch Corp.
Ophthalmic · 92d
Cleared May 17, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747...
K940649 · LDJ
Microgenics Corp.
Toxicology · 91d
Cleared May 17, 1994
86 HQY SUNGLASSES
K940705 · HQY
Firestar, Inc.
Ophthalmic · 89d
Cleared May 17, 1994
NONE-GENERIC
K940728 · HQY
Dyer Intl.
Ophthalmic · 88d
Cleared May 17, 1994
SUNGLASSES
K940943 · HQY
Kendward Industrial Corp.
Ophthalmic · 78d
Cleared May 17, 1994
SUNGLASSES
K940945 · HQY
Hi-Shine Ent. Co., Ltd.
Ophthalmic · 76d
Cleared May 17, 1994
ALPINA EYEWEAR
K941060 · HQY
Alpina High Tech Sports Eyewear
Ophthalmic · 70d
Cleared May 17, 1994
LIPASE-PS ASSAY PROCEDURE NO. 805
K941085 · CHI
Sigma Diagnostics, Inc.
Chemistry · 70d
Cleared May 17, 1994
PARAKIT
K941110 · LKS
Hardy Diagnostics
Microbiology · 71d
Cleared May 17, 1994
NON-PRESCRIPTION SUNGLASSES
K941186 · HQY
Sungold Ent. , Ltd.
Ophthalmic · 64d
Cleared May 17, 1994
SUNGLASSES (NON PRESCRIPTION)
K941280 · HQY
Autotime Industry, Inc.
Ophthalmic · 61d
Cleared May 17, 1994
SPECTACLE FRAMES
K941307 · HQZ
Eyemart Express, Inc.
Ophthalmic · 61d
Cleared May 17, 1994
STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
K941313 · CJE
Stanbio Laboratory
Chemistry · 60d
Cleared May 17, 1994
CHANG CHENG CHUNG
K941338 · HQY
Designer Brass Corp.
Ophthalmic · 57d
Cleared May 17, 1994
BORRION ENTERPRISE CO
K941340 · HQY
Borrion Enterprise Co.
Ophthalmic · 57d
Cleared May 17, 1994
AVON CAT SUNGLASSES
K941369 · HQY
Siegel,Mandell & Davidson,P.C.
Ophthalmic · 57d
Cleared May 17, 1994
SUNGLASSES
K941380 · HQY
Spare Parts Accessories
Ophthalmic · 56d
Cleared May 17, 1994
CHIN HSIEU CHENG
K941410 · HQY
Large River Industrial Co., Ltd.
Ophthalmic · 55d
Cleared May 17, 1994
SUNGLASSES
K941502 · HQY
Asia Pacific Trading Co., Inc.
Ophthalmic · 49d