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
168193–168216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1979
TC02M ELECTRODE ADHESIVE RINGS
K792010 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 21d
Cleared Oct 26, 1979
SKIL-CARE SUPER-SOFT LIMB RESTRAINTS
K792012 · FMQ
Skil-Care Corp.
General Hospital · 21d
Cleared Oct 26, 1979
DISCARD-A-PAD 40-COUNT SHARPS DISPOSAL
K792016 · MMK
Arbrook Mfg. Corp.
General Hospital · 21d
Cleared Oct 26, 1979
LARGE VOLUME 5 MICRON CONICAL FILTER
K792021 · FPB
National Patent Development Corp.
General Hospital · 17d
Cleared Oct 26, 1979
HERBERT BONE SCREW
K792022 · HWC
Zimmer, Inc.
Orthopedic · 17d
Cleared Oct 26, 1979
OTOTOME BUR
K792028 · EQJ
American Sterilizer Co.
Ear, Nose, Throat · 17d
Cleared Oct 26, 1979
FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE
K792035 · BTR
Bivona Medical Technologies
Anesthesiology · 16d
Cleared Oct 26, 1979
AORTIC OCCLUDER #000390
K792088 · DWS
Edward Weck, Inc.
Cardiovascular · 9d
Cleared Oct 26, 1979
50MM WRITER MODEL CVM 9529
K792099 · DSF
C-V Monitors Corp.
Cardiovascular · 7d
Cleared Oct 26, 1979
CRITIKON DUAL CHANNEL RECORDER
K792105 · DSF
Critikon Company, LLC
Cardiovascular · 4d
Cleared Oct 23, 1979
EMPTY TRANSFER BAG
K791673 · KSR
Delmed, Inc.
Hematology · 56d
Cleared Oct 23, 1979
PLAQUE-X DENTURE CLEANSER
K791716 · JER
Noxell
Dental · 53d
Cleared Oct 23, 1979
ULTRAVUE BLENDED BIFOCAL LENS
K791721 · HQG
American Optical Corp.
Ophthalmic · 54d
Cleared Oct 23, 1979
LIGHT-PAK
K791733 · EAY
Midwest
Dental · 56d
Cleared Oct 22, 1979
VISIO-DISPERS
K790823 · EBF
Espe GmbH (Us)
Dental · 174d
Cleared Oct 22, 1979
KLIP-LITE
K790984 · EAZ
Innovators, Inc.
Dental · 150d
Cleared Oct 22, 1979
MONOJECT PULP-CAPPING MATERIAL
K791088 · EJK
Sherwood Medical Co.
Dental · 132d
Cleared Oct 22, 1979
EMS ADAPTER MODEL 9160
K791541 · GEI
Concept, Inc.
General & Plastic Surgery · 73d
Cleared Oct 22, 1979
THE DENVER SPLINT
K791681 · EPP
Xomed, Inc.
Ear, Nose, Throat · 55d
Cleared Oct 22, 1979
HYDRADJUST II UROLOGICAL TABLE
K791699 · KQS
Sybron Corp.
Gastroenterology & Urology · 54d
Cleared Oct 22, 1979
VENTILATOR TUBE WITH FILTER
K791773 · CAH
Pharmaseal Div., Baxter Healthcare Corp.
General Hospital · 42d
Cleared Oct 22, 1979
OMNI-STANICOR (THETA) MOD 237A
K791783 · DXY
Cordis Corp.
Cardiovascular · 41d
Cleared Oct 22, 1979
MICRO-RING SYSTEM PRECISION ATTACH.
K791788 · EGG
Howmedica Corp.
Dental · 41d
Cleared Oct 22, 1979
I.V. START SET
K791885 · KGX
Ascep, Inc.
General & Plastic Surgery · 41d