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
173113–173136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 1977
ACCU-PAQUE
K771886 · EIH
Williams Gold Refining Co., Inc.
Dental · 40d
Cleared Nov 14, 1977
ACCU-STAIN
K771887 · EIH
Williams Gold Refining Co., Inc.
Dental · 40d
Cleared Nov 14, 1977
IRON SET, ITEM NO. 65008
K771927 · JMO
Harleco
Chemistry · 31d
Cleared Nov 14, 1977
CALCIUM SET, ITEM NO. 65004
K771928 · CJY
Harleco
Chemistry · 31d
Cleared Nov 14, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT
K772030 · CKA
Harleco
Chemistry · 18d
Cleared Nov 14, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT
K772031
Harleco
Chemistry · 18d
Cleared Nov 14, 1977
THYRODOT-4 ANTISERA LYOPHOLIZED
K772064 · CDX
Medcom Diagnostics, Inc.
Immunology · 12d
Cleared Nov 14, 1977
ULTRASONIC DENTURE CLEANER
K772087 · EFT
Clairol, Inc.
Dental · 11d
Cleared Nov 14, 1977
TIME WATCH
K772119 · FPK
Akzona, Inc.
General Hospital · 12d
Cleared Nov 11, 1977
ELHCTRONIC SPHYGMOMANOMETER
K771393 · DXN
C.R. Bard, Inc.
Cardiovascular · 106d
Cleared Nov 11, 1977
TMA BICARBONATE/GLYCEROL DILUENT
K771700
Hyland Therapeutic Div., Travenol...
Chemistry · 65d
Cleared Nov 11, 1977
FASTCHEM BUN
K771923 · CDQ
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Nov 11, 1977
TOTAL PROTEIN SET, ITEM NO. 64010
K771926 · CEK
Harleco
Chemistry · 28d
Cleared Nov 11, 1977
SPECTROPHOTOMETER CARY 219
K772022 · JJQ
Varian Assoc., Inc.
Chemistry · 16d
Cleared Nov 11, 1977
URIC ACID STD. FOR QUANT. URIC ACID
K772025 · JIS
Worthington Biochemical Corp.
Chemistry · 15d
Cleared Nov 11, 1977
WALKING AID
K772049 · ITJ
Guardian Products Co., Inc.
Physical Medicine · 11d
Cleared Nov 11, 1977
NAIL, INTRAMEDULLARY, FLEXIBLE
K772081 · HSB
Depuy, Inc.
Orthopedic · 8d
Cleared Nov 11, 1977
LAPAROTOMY SPOGNE
K772089 · EFQ
General Medical Co.
General & Plastic Surgery · 7d
Cleared Nov 09, 1977
ELECTRONIC STETHESCOPE
K771394 · DXN
C.R. Bard, Inc.
Cardiovascular · 104d
Cleared Nov 09, 1977
COUNTER MODEL S PLUS BLOOD CELL COUNTER
K771512 · GKL
Coulter Electronics, Inc.
Chemistry · 93d
Cleared Nov 09, 1977
DIAG. KIT FOR TOTAL ANTITHROMBIN III
K771669 · JBQ
Abbott Laboratories
Hematology · 69d
Cleared Nov 09, 1977
ECG CLUSTER ELECTRODE
K771776 · DRX
C.R. Bard, Inc.
Cardiovascular · 51d
Cleared Nov 09, 1977
TROUTMAN CORNEAL PUNCH
K771866 · HRH
Edward Weck, Inc.
Ophthalmic · 37d
Cleared Nov 09, 1977
REPLICA BONDING AGENT
K771881
Hoyt Laboratories
Dental · 36d