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
124345–124368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1990
MODEL 1850 ELECTRODE
K903918 · DRX
Medtronic Vascular
Cardiovascular · 68d
Cleared Oct 31, 1990
ELLA BREAST FORM
K904085 · KCZ
Coloplast A/S
General & Plastic Surgery · 56d
Cleared Oct 31, 1990
SENSATRACE
K904185 · DRX
Ludlow Corp., Technical Papers Division
Cardiovascular · 49d
Cleared Oct 31, 1990
SUCTION SYSTEM
K904218 · GEA
Axiom Medical, Inc.
General & Plastic Surgery · 49d
Cleared Oct 31, 1990
MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
K904273 · LTZ
Carter Products
Obstetrics & Gynecology · 44d
Cleared Oct 31, 1990
ARGENCO 22
K904343 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Oct 31, 1990
ARGILITE 3
K904467 · EIT
Argen Precious Metals, Inc.
Dental · 30d
Cleared Oct 31, 1990
ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID
K904544 · EWO
Qualitone
Ear, Nose, Throat · 27d
Cleared Oct 31, 1990
MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN
K904701 · BYX
Medical Fittings, Inc.
Anesthesiology · 15d
Cleared Oct 31, 1990
MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS
K904702 · BYX
Medical Fittings, Inc.
Anesthesiology · 15d
Cleared Oct 31, 1990
OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS
K904757 · BYX
Medical Fittings, Inc.
Anesthesiology · 12d
Cleared Oct 31, 1990
TKO TELESCOPING LITHOTOMY STIRRUP
K904826 · FWZ
D.L. Nelson and Assoc., Inc.
General & Plastic Surgery · 6d
Cleared Oct 30, 1990
LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER
K902056 · JDY
Hollister, Inc.
Orthopedic · 176d
Cleared Oct 30, 1990
FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM
K902149 · FKX
Fresenius/Delmed, Inc.
Gastroenterology & Urology · 168d
Cleared Oct 30, 1990
SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER
K902778 · HRX
Surgical Dynamics, Inc.
Orthopedic · 127d
Cleared Oct 30, 1990
OSTEONICS DRM ACETABULAR COMPONENT
K903636 · JDI
Osteonics Corp.
Orthopedic · 78d
Cleared Oct 30, 1990
QUALTEX NEEDLE COUNTERS
K903947 · MMK
Deroyal Industries, Inc.
General Hospital · 64d
Cleared Oct 30, 1990
STI DRAPE SHEET STYLE 1908
K904112 · KKX
Sterilizer Technologies Corp.
General Hospital · 54d
Cleared Oct 30, 1990
OPERATIVE RECORDING CAMERA
K904113 · IKO
Medical Dynamics, Inc.
Physical Medicine · 54d
Cleared Oct 30, 1990
VISIRASER
K904126 · GEX
Acorn Group, Inc.
General & Plastic Surgery · 54d
Cleared Oct 30, 1990
MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP
K904578 · GET
United States Surgical, A Division of...
General & Plastic Surgery · 28d
Cleared Oct 30, 1990
ACCU PATH STERILE LABEL
K904598 · LDQ
Accu-Path
General & Plastic Surgery · 20d
Cleared Oct 29, 1990
PREEMICARE NEBUTECH NEBULIZER SYSTEM
K896375 · CAF
Preemicare Corp.
Anesthesiology · 357d
Cleared Oct 29, 1990
PROMATRON 3000
K901566 · IKK
Promatek Medical Systems, Inc.
Physical Medicine · 209d