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
123193–123216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 1991
MYOCARDIAL TEMPERATURE MONITORING PROBES, CJ-1000
K905652 · FLL
Daily Medical Products, Inc.
General Hospital · 58d
Cleared Feb 14, 1991
TENONE(TM) METHAMPHETAMINE
K910043 · LAF
Diagnostic Products Corp.
Toxicology · 41d
Cleared Feb 14, 1991
DATA RECORDER
K910118 · FLL
Healthdyne, Inc.
General Hospital · 34d
Cleared Feb 14, 1991
TRAVELER, MOTORIZED THREE-WHEELED VEHICLE
K910265 · INI
Pillar Technology, Inc.
Physical Medicine · 27d
Cleared Feb 14, 1991
IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR
K910455 · FMI
Ziehm International, Inc.
General Hospital · 13d
Cleared Feb 13, 1991
7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)
K902728 · ITX
Ausonics Pty , Ltd.
Radiology · 237d
Cleared Feb 13, 1991
G.E. DXD 325/350/350II/DXD 525/525II GENERATORS
K902986 · IZO
Electromek Diagnostic Systems, Inc.
Radiology · 232d
Cleared Feb 13, 1991
PRIMARY MANUFACTURER SUNGLASSES
K903065 · HQY
Mao Lin Ent.
Ophthalmic · 219d
Cleared Feb 13, 1991
AVALON GENERAL PURPOSE SCANNER, PREVIEW GP
K904317 · DPW
Avalon Technology Corp.
Cardiovascular · 146d
Cleared Feb 13, 1991
WHITESIDE ORTHOLOC MODULAR TIBIAL CONSTRAIN.INSERT
K905076 · JWH
Dow Corning Wright
Orthopedic · 92d
Cleared Feb 13, 1991
HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES
K905155 · EFB
Star Dental Mfg. Co.
Dental · 90d
Cleared Feb 13, 1991
TUBE DECLOGGER
K905164 · KNT
Nova Design Technologies, Ltd.
Gastroenterology & Urology · 89d
Cleared Feb 13, 1991
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II
K905477 · JIS
Em Diagnostic Systems, Inc.
Chemistry · 69d
Cleared Feb 13, 1991
CREATININE (RATE) REAGENT SET
K905619 · CGX
Biochemical Trade, Inc.
Chemistry · 61d
Cleared Feb 13, 1991
KINETIC ALKALINE PHOSPHATASE DETERMINATION
K905650 · CJE
Biochemical Trade, Inc.
Chemistry · 57d
Cleared Feb 13, 1991
BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
K905707 · FGE
Baxter Healthcare Corp
Gastroenterology & Urology · 54d
Cleared Feb 13, 1991
CLEARBLUE EASY
K905742 · LCX
Unipath , Ltd.
Chemistry · 51d
Cleared Feb 13, 1991
VPW2877E7 X RAY POWER SUPPLY
K905855 · IZO
Varian Canada, Inc.
Radiology · 54d
Cleared Feb 13, 1991
AVD INTIMAX (TM) BILIARY CATHETER
K910006 · FGE
Applied Vascular
Gastroenterology & Urology · 42d
Cleared Feb 13, 1991
MILENIA COCAINE METABOLITE
K910044 · KLN
Diagnostic Products Corp.
Toxicology · 40d
Cleared Feb 13, 1991
K-MODULE II HEAT THERAPY SYSTEM
K910061 · ILO
Baxter Healthcare Corp
Physical Medicine · 35d
Cleared Feb 13, 1991
CHILDREN SUNGLASSES
K910141 · HQY
Consolidated Stores Intl. Corp.
Ophthalmic · 30d
Cleared Feb 13, 1991
STRATUS ESTRADIOL FLUOREMETRIC ENZYME
K910249 · CHP
Baxter Healthcare Corp
Chemistry · 22d
Cleared Feb 12, 1991
MAXI ASPIRATOR
K902184 · BTI
Medical Industries America, Inc.
Anesthesiology · 274d