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
164353–164376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1981
DISPOSABLE UNDERPADS
K811232 · KME
Burina
General Hospital · 17d
Cleared May 21, 1981
DISPOSABLE STERILIZATION WRAP
K811242 · FRG
Amsco Co.
General Hospital · 17d
Cleared May 21, 1981
TECHNICON SMAC II SYSTEM & ACCESSORIES
K811249 · JJC
Technicon Instruments Corp.
Chemistry · 16d
Cleared May 21, 1981
CITRATE BUFFER
K811251 · JCC
Bioscientific
Chemistry · 16d
Cleared May 20, 1981
SPENCO DERMAL PADS
K811184 · FMP
Spenco Medical Corp.
General Hospital · 21d
Cleared May 18, 1981
SC/TEMP 300
K810332 · HCC
Thought Technology , Ltd.
Neurology · 98d
Cleared May 15, 1981
GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I
K810043 · GQM
Vibac Corp.
Microbiology · 128d
Cleared May 15, 1981
APC IMPLANTABLE PACING LEAD, TINED #3262
K810396 · DTB
American Pacemaker Corp.
Cardiovascular · 86d
Cleared May 15, 1981
APC IMPLANTABLE PACING LEAD-FLANGE #3260
K810397 · DTB
American Pacemaker Corp.
Cardiovascular · 86d
Cleared May 15, 1981
APC IMPLANTABLE PACING LEAD, MODEL 3266
K810398 · DTB
American Pacemaker Corp.
Cardiovascular · 86d
Cleared May 15, 1981
APC IMPLANTABEL PACING LEAD, MODEL 3264
K810399 · DTB
American Pacemaker Corp.
Cardiovascular · 86d
Cleared May 15, 1981
MODELS 8420 THRU 8423 PACEMAKER GENER
K810734 · DXY
Medtronic Vascular
Cardiovascular · 58d
Cleared May 15, 1981
CORATOMIC MODEL OVALITH-920
K810808 · DXY
Coratomic, Inc.
Cardiovascular · 52d
Cleared May 15, 1981
FOGARTY FLEXIBLE CALIBRATOR
K810894 · DWP
American Edwards Laboratories
Cardiovascular · 42d
Cleared May 15, 1981
ANIS IRRIGATING SPATULA
K810937 · HND
American V. Mueller
Ophthalmic · 38d
Cleared May 15, 1981
HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE
K811011 · GIA
Sigma Chemical Co.
Toxicology · 30d
Cleared May 15, 1981
POSITIVE CLOSURE ANESTHETIC VALVE
K811015 · CAI
Orthopedic Systems, Inc.
Anesthesiology · 30d
Cleared May 15, 1981
ARIA II INSULIN RIA
K811144 · CFP
Bd Becton Dickinson Vacutainer...
Chemistry · 18d
Cleared May 15, 1981
URINE PREGNANCY TEST STANDARD/CONTR. PK
K811150 · JJX
Mallinckrodt Critical Care
Chemistry · 18d
Cleared May 15, 1981
COLLARLESS TOTAL HIP FEMORAL COMP. SYS
K811151 · JDI
Howmedica Corp.
Orthopedic · 18d
Cleared May 15, 1981
DADE RPR CARD TEST
K811152 · GMQ
American Dade
Microbiology · 18d
Cleared May 15, 1981
PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT
K811169 · JFH
Amersham Corp.
Chemistry · 17d
Cleared May 15, 1981
TIGGES SPINAL
K811176 · IPW
The Tiggs Co.
Physical Medicine · 17d
Cleared May 15, 1981
QUANTA PHASE VITAMIN B-12/FOLATE RAD
K811177 · CGN
Bio-Rad
Chemistry · 17d