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

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175,820 results
124873–124896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 1990
CARTIER SUNGLASSES, MUST DE
K900907 · HQY
Cartier, Inc.
Ophthalmic · 204d
Cleared Sep 19, 1990
DORR KNEE SYSTEM
K901085 · JWH
Intermedics Orthopedics
Orthopedic · 194d
Cleared Sep 19, 1990
CHEMFIL II CAPS
K901524 · EMA
Dentsply Intl.
Dental · 170d
Cleared Sep 19, 1990
CENTRAL VENOUS ACCESS CATHETER
K901701 · FOZ
Cardiopulmonics, Inc.
General Hospital · 160d
Cleared Sep 19, 1990
5 MM IRRIGATION/ASPIRATION FIBER PROBE
K902258 · HET
Hgm Medical Laser Systems, Inc.
Obstetrics & Gynecology · 121d
Cleared Sep 19, 1990
AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET
K902432 · FRN
Abbott Laboratories
General Hospital · 111d
Cleared Sep 19, 1990
GYNESCOPE LAPAROSCOPIC FORCEPS
K902657 · HET
Gynescope Corp.
Obstetrics & Gynecology · 96d
Cleared Sep 19, 1990
GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES
K902658 · KNF
Gynescope Corp.
Obstetrics & Gynecology · 96d
Cleared Sep 19, 1990
LATEX SURGICAL GLOVES (YUETONG ENTERPRISE CO. LTD)
K902714 · KGO
Quinhuangda Yuetong Ent. Co., Ltd.
General Hospital · 91d
Cleared Sep 19, 1990
NAPA
K902790 · LQZ
G-Ortho Lab
Dental · 85d
Cleared Sep 19, 1990
CUSTOMED BASIC PACK I
K902884 · KKX
Customed, Inc.
General Hospital · 79d
Cleared Sep 19, 1990
CUSTOMED BASIC PACK II
K902885 · KKX
Customed, Inc.
General Hospital · 79d
Cleared Sep 19, 1990
CUSTOMED BASIC PACK III
K902886 · KKX
Customed, Inc.
General Hospital · 79d
Cleared Sep 19, 1990
MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER
K903007 · EJI
Habley Medical Technology Corp.
Dental · 70d
Cleared Sep 19, 1990
DISPOSABLE PLASTIC VAGINAL SPECULUM
K903080 · HIB
Dawnex Industries, Inc.
Obstetrics & Gynecology · 69d
Cleared Sep 19, 1990
OTOSCREENER-I AND OTO-SCREEN-I-P
K903143 · EWO
Handtronix, Inc.
Ear, Nose, Throat · 63d
Cleared Sep 19, 1990
TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN
K903414 · DXK
Echo Ultrasound
Cardiovascular · 51d
Cleared Sep 19, 1990
STERILE LATEX EXAMINATION GLOVES
K903447 · LYY
Sime Darby USA
General Hospital · 54d
Cleared Sep 19, 1990
ARGENCO 8 GOLD ALLOY FOR PORCELAIN
K903678 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Sep 19, 1990
THERA-CANE
K903820 · LYG
Pro Message Co.
Physical Medicine · 30d
Cleared Sep 19, 1990
VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES
K903883 · GEX
Metatech Corp.
General & Plastic Surgery · 28d
Cleared Sep 19, 1990
S.P.F. PREMIER 2 WHEELCHAIR
K904152 · IOR
Everest & Jennings, Inc.
Physical Medicine · 12d
Cleared Sep 19, 1990
PATIENT EXAMINATION GLOVES
K904190 · LYY
1st Med, Inc.
General Hospital · 7d
Cleared Sep 18, 1990
CURAPULS 403 DIATHERMY UNIT
K900189 · IMG
Henley Intl.
Physical Medicine · 245d