Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
162697–162720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1981
ETHICON* SURGICAL SUTURES W/COMPRESS BOL
K812819 · KGS
Ethicon, Inc.
General & Plastic Surgery · 44d
Cleared Nov 20, 1981
SURGICAL LOOPS
K812875 · GAD
M-W Laboratories, Inc.
General & Plastic Surgery · 37d
Cleared Nov 20, 1981
SURGICAL PAWS
K812876 · GDZ
M-W Laboratories, Inc.
General & Plastic Surgery · 37d
Cleared Nov 20, 1981
BOUNDARY SURGICAL DRAPE
K812962 · KKX
The Buckeye Cellulose Corp.
General Hospital · 29d
Cleared Nov 20, 1981
STERILE IRRIGATING SYRINGES, KITS,TRAY
K813027 · KYZ
Welcon, Inc.
General Hospital · 23d
Cleared Nov 20, 1981
PERIOGRAF
K813070 · LYC
Sterling Drug, Inc.
Dental · 18d
Cleared Nov 20, 1981
HEPAFIX BIOPSY NEEDLE SET
K813085 · KNW
Burron Medical Products, Inc.
Gastroenterology & Urology · 18d
Cleared Nov 20, 1981
CEMENT RING
K813089 · JDI
Biomet, Inc.
Orthopedic · 18d
Cleared Nov 20, 1981
RICHARDS ACETABULAR BRUSH
K813093 · HTR
Richard'S Medical Equip., Inc.
General & Plastic Surgery · 18d
Cleared Nov 20, 1981
ACETABULAR CEMENT COMPRESSOR
K813094
Richard'S Medical Equip., Inc.
Orthopedic · 17d
Cleared Nov 20, 1981
TENS DEVICE
K813098
Staodynamics, Inc.
Neurology · 17d
Cleared Nov 20, 1981
POWER DRIVE WHEELCR
K813104 · ITI
Intl. Medical Equipment Corp.
Physical Medicine · 17d
Cleared Nov 20, 1981
KEYMED KEY LIGHT
K813133 · HET
Keymed, Inc.
Obstetrics & Gynecology · 15d
Cleared Nov 17, 1981
PENTAX FLEXIBLE DRIODENOFIBERSCOPE
K812810 · FAK
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 42d
Cleared Nov 17, 1981
ROBINSON CATHETERS NON-STERILE
K812887 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 34d
Cleared Nov 17, 1981
ESTILUX POSTERIOR
K812889 · EBF
Kulzer, Inc.
Dental · 33d
Cleared Nov 17, 1981
GUIDE WIRE
K813026 · OCY
Inmed Corp.
Gastroenterology & Urology · 20d
Cleared Nov 17, 1981
WOUND DRAINAGE MANAGEMENT SYSTEMS
K813080 · EXB
Howmedica Corp.
Gastroenterology & Urology · 15d
Cleared Nov 16, 1981
EXTRASENSR ULTRAFILTRATION MONITOR
K811972 · FKP
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 129d
Cleared Nov 16, 1981
PRUITT ARTERIAL OCCLUSION CHOLANG. CATH
K812111 · DYG
Bionomy, Inc.
Cardiovascular · 112d
Cleared Nov 16, 1981
DIGICLOT 2-#820
K812121 · JPA
Volu Sol Medical Industries
Hematology · 112d
Cleared Nov 16, 1981
ULTRA COM
K812209 · DXK
Ultranamics, Inc.
Cardiovascular · 104d
Cleared Nov 16, 1981
MODEL 900S INTRAOCULAR PROBE
K812219 · HQF
Lumenis, Inc.
Ophthalmic · 102d
Cleared Nov 16, 1981
VARIABLE FOCUS 3.5 MHZ TRANSDUCER
K812301 · ITX
Adr Ultrasound
Radiology · 94d