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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
167857–167880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1979
COTTON ROLL COMPRESSION CAPS
K792391 · EFN
Parker Laboratories, Inc.
Dental · 10d
Cleared Dec 06, 1979
ELVI CALCIUM
K792396 · CIA
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
ELVI ALBUMIN
K792408 · CIX
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
ELVI TOTAL IRON BINDING CAPACITY
K792409 · JQF
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
ELVI SGOT & SGPT TRANSAMINASE
K792410 · CIS
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
ELVI TOTAL BILIRUBIN & FRACTIONS
K792411 · CIG
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
MW STRAIGHT ATTACHMENT
K792445 · EGS
Midwest
Dental · 6d
Cleared Dec 05, 1979
ACU-MED RED MISER HEMOTHORAX BLOOD COLL.
K791891 · CAC
Acumed Instruments Corp.
Anesthesiology · 71d
Cleared Dec 05, 1979
CONPHAR MANOMETER CONNECTORS
K792113 · DTL
Conphar, Inc.
Cardiovascular · 41d
Cleared Dec 05, 1979
CONTINUOUS FLUSH DEVICE
K792141 · KRA
Pharmaseal Div., Baxter Healthcare Corp.
Cardiovascular · 44d
Cleared Dec 05, 1979
DISPOSA-HOOD
K792144 · FOG
Utah Medical Products, Inc.
Anesthesiology · 43d
Cleared Dec 05, 1979
AUTOMATIC RETRACTOR HOLDERS
K792145 · GAD
Automated Medical Products, Inc.
General & Plastic Surgery · 43d
Cleared Dec 05, 1979
HOWMEDICA MIX-KIT II
K792186 · JDZ
Howmedica Corp.
Orthopedic · 35d
Cleared Dec 05, 1979
TILLMAN HIP RESURFACING REPLACEMT PROS.
K792200 · KXA
Waldemar Link GmbH & Co. KG
Orthopedic · 34d
Cleared Dec 05, 1979
CURVED KUNTSCHER INTRAMEDULLARY NAIL
K792203 · HSB
Howmedica Corp.
Orthopedic · 33d
Cleared Dec 05, 1979
HOWMEDICA COMPRESSION STAPLE SYSTEM
K792204 · JDR
Howmedica Corp.
Orthopedic · 33d
Cleared Dec 05, 1979
HEARING AID, UNITRON MODEL 905W
K792237 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 29d
Cleared Dec 05, 1979
POLYCENTRIC TOTAL KNEE METAL TIBIAL
K792240 · HSX
Howmedica Corp.
Orthopedic · 28d
Cleared Dec 05, 1979
ARICULATED TENSION DEVICE SYNTHES TEN
K792253 · HWN
Synthes (Usa)
Orthopedic · 28d
Cleared Dec 05, 1979
STANICOR, OMNI-STAN,MOD 333B,334A GAMMA
K792348 · DTX
Cordis Corp.
Cardiovascular · 16d
Cleared Dec 05, 1979
MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE
K792351 · GXY
Medtronic Vascular
Neurology · 16d
Cleared Dec 05, 1979
ANEROID SPHYMOMANOMETER
K792355 · DXQ
Abco Dealers, Inc.
Cardiovascular · 14d
Cleared Dec 05, 1979
MEDTRONIC MODEL 9407 TELETRACE TRANSMITT
K792359 · DXH
Medtronic Vascular
Cardiovascular · 14d
Cleared Dec 05, 1979
CARDIAC PACING ELECTRODE
K792379 · DTB
Medi-Dyne Instruments, Inc.
Cardiovascular · 9d