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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
117073–117096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1992
COMFEEL CONTOUR DRESSING
K920925 · KMF
Coloplast A/S
General & Plastic Surgery · 90d
Cleared May 28, 1992
BO POWER SUPPLY
K921046 · LNH
Resonex, Inc.
Radiology · 85d
Cleared May 28, 1992
RLS 9100 RHINO-LARYNGEAL STROBOSCOPE
K921184 · EQL
Kay Elemetrics Corp.
Ear, Nose, Throat · 80d
Cleared May 28, 1992
9105 RIGID TELESCOPIC ENDOSCOPE
K921285 · EQL
Kay Elemetrics Corp.
Ear, Nose, Throat · 72d
Cleared May 28, 1992
ADAC S315
K921296 · IYX
Adac Laboratories
Radiology · 72d
Cleared May 28, 1992
CAPTUS 500
K921428 · IZD
Capintec Instruments, Inc.
Radiology · 65d
Cleared May 28, 1992
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF
K921432 · JAK
Shimadzu Medical Systems
Radiology · 64d
Cleared May 28, 1992
P2900 X-RAY GENERATOR
K921516 · IZO
Precise Optics Photo Medic Equipment,...
Radiology · 58d
Cleared May 28, 1992
IGG SUCLASS EIA
K921575 · DEW
Virotech Diagnostika
Immunology · 56d
Cleared May 28, 1992
DIRECTDRAW SUPERSERUM
K921778 · GIM
International Technidyne Corp.
Chemistry · 44d
Cleared May 28, 1992
MODIFICATION PURITAN-BENNETT INFANT PM2
K922004 · BTM
Puritan Bennett Corp.
Anesthesiology · 29d
Cleared May 27, 1992
DISPOSABLE STYLETTE WITH END CAP
K914965 · BSR
Pivic Promedco
Anesthesiology · 204d
Cleared May 27, 1992
GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS
K915154 · CAN
C.G.H. Medical, Inc.
Anesthesiology · 195d
Cleared May 27, 1992
ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN
K920194 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 133d
Cleared May 27, 1992
3M DIGITAL DISK INTERFACE UNIT
K920268 · LMD
3M Company
Radiology · 127d
Cleared May 27, 1992
ORTHODERM CONVERTIBLE II
K922140 · IOQ
Bio Clinic Co.
Physical Medicine · 21d
Cleared May 27, 1992
OTOSONIC ACS-IC
K922224 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 15d
Cleared May 26, 1992
HEART NUBULIZER
K920332 · CAF
Vortran Medical Technology 1, Inc.
Anesthesiology · 124d
Cleared May 26, 1992
ACETABULAR DOME AND SCREW HOLE PLUGS
K920868 · JDL
Osteonics Corp.
Orthopedic · 90d
Cleared May 26, 1992
FORTRESS 760-N 4 WHEEL POWER WHEELCHAIR
K921070 · ITI
Fortress Scientific , Ltd.
Physical Medicine · 89d
Cleared May 26, 1992
AVI MODEL 470CI INFUSION PUMP
K921072 · FRN
3M Health Care, Ltd.
General Hospital · 81d
Cleared May 26, 1992
AVI MODEL 480CI INFUSION PUMP
K921073 · FRN
3M Health Care, Ltd.
General Hospital · 81d
Cleared May 26, 1992
FORCE MEASURING PLATFORM
K921340 · KHX
Sra Intl., Inc.
Physical Medicine · 67d
Cleared May 26, 1992
DEVA PLUS
K921419 · EJS
Degussa AG
Dental · 63d