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
125401–125424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1990
THE MYOLOC SYSTEM
K900678 · EJF
Winder Research, Inc.
Dental · 181d
Cleared Aug 13, 1990
DEGUFILL (R) POLISHING GEL
K901873 · EJR
Degussa AG
Dental · 111d
Cleared Aug 13, 1990
ENDOMETRIAL SAMPLER
K901896 · EJF
Kirwan Surgical Products, Inc.
Dental · 110d
Cleared Aug 13, 1990
AURA CERAMIC DENTAL APPLIANCE
K902390 · EJF
Progressive Technology, Inc.
Dental · 75d
Cleared Aug 13, 1990
SONIC SCALER
K902413 · ELC
Dentsply Intl.
Dental · 74d
Cleared Aug 13, 1990
DEGUFILL (TM)
K902745 · EBF
Degussa AG
Dental · 52d
Cleared Aug 13, 1990
EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT
K902804 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 47d
Cleared Aug 13, 1990
ARGENCO III
K903009 · EJS
Argen Precious Metals, Inc.
Dental · 35d
Cleared Aug 13, 1990
ARGENCO 34
K903060 · EJS
Argen Precious Metals, Inc.
Dental · 35d
Cleared Aug 13, 1990
ARGENCO 7A
K903118 · EJT
Argen Precious Metals, Inc.
Dental · 28d
Cleared Aug 13, 1990
ARGENCO 5
K903232 · EJT
Argen Precious Metals, Inc.
Dental · 21d
Cleared Aug 13, 1990
ARGENCO 36
K903275 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Aug 13, 1990
ARGENCO 33 KF
K903276 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Aug 13, 1990
ARGICAST B
K903277 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Aug 13, 1990
ARGENCO 75
K903279 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Aug 13, 1990
ARGENCO 4
K903281 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Aug 13, 1990
ARGENCO 12
K903282 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Aug 13, 1990
ARGENCO IV
K903283 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Aug 13, 1990
DENTALON PLUS
K903317 · EBG
Kulzer, Inc.
Dental · 19d
Cleared Aug 10, 1990
BARNES FEMORAL LENGTHENING DEVICE
K895243 · HRS
Piedmont Sports Medicine &...
Orthopedic · 354d
Cleared Aug 10, 1990
SONOACE 88 PORTABLE ULTRASOUND SCANNER
K900505 · HEM
Medison Co., Ltd.
Obstetrics & Gynecology · 189d
Cleared Aug 10, 1990
ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER
K901335 · DPW
Ge Medical Systems Information...
Cardiovascular · 141d
Cleared Aug 10, 1990
ELASTYREN - EXAMINATION AND DENTAL GLOVES
K901394 · LZA
Danpren Gloves A/S
General Hospital · 137d
Cleared Aug 10, 1990
MULTICATH PLACEMENT KIT
K901640 · FOZ
Vygon Corp.
General Hospital · 123d