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
171289–171312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1978
EMIT PROCAINAMIDE ASSAY
K781382 · LAR
Syva Co.
Toxicology · 67d
Cleared Oct 17, 1978
MIC-BIO-PLATE
K781506 · JSF
Pasco Laboratories, Inc.
Microbiology · 84d
Cleared Oct 17, 1978
ECG ELECTRODE, 2021, 2022, 2032, 2033
K781514 · DRX
Cardio-Dynamics Laboratories, Inc.
Cardiovascular · 46d
Cleared Oct 17, 1978
MAXIRAY 125 TUBE UNIT
K781524 · ITY
General Electric Co.
Radiology · 42d
Cleared Oct 17, 1978
SEPTAL BUTTON
K781529 · LFB
Xomed, Inc.
Ear, Nose, Throat · 42d
Cleared Oct 17, 1978
UMBILICAL CORD CLAMP
K781548 · HFW
Hollister, Inc.
Obstetrics & Gynecology · 35d
Cleared Oct 17, 1978
PRESSURE INFUSION CUFF
K781556 · DXN
Abbott Laboratories
Cardiovascular · 36d
Cleared Oct 17, 1978
24-HOUR URINE COLLECTION COOLING WRAP
K781557 · FMH
Sage Products, Inc.
General Hospital · 36d
Cleared Oct 17, 1978
RIA DIAG. TEST KIT FOR INDEXING THYROX.
K781560 · CEC
Nuclear Diagnostics, Inc.
Chemistry · 36d
Cleared Oct 17, 1978
NORMAL HEMATOLOGY CONTROL UNASSAYED
K781572 · JPK
Ortho Diagnostics, Inc.
Hematology · 33d
Cleared Oct 17, 1978
ABNORMAL HEMATOLOGY CONTROL UNASSAYED
K781573 · JPK
Ortho Diagnostics, Inc.
Hematology · 33d
Cleared Oct 17, 1978
SURGICAL LIGHT 22 SERIES
K781581 · FQP
American Sterilizer Co.
General & Plastic Surgery · 32d
Cleared Oct 17, 1978
RIA CONTROLS
K781593 · JJY
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 29d
Cleared Oct 17, 1978
TECHNICON AUTOSLIDE STAINING/PROCESSING
K781598 · KPA
Technicon Instruments Corp.
Hematology · 29d
Cleared Oct 17, 1978
I-ESTRIOL TEST SET
K781599 · CGI
Wien Laboratories, Inc.
Hematology · 29d
Cleared Oct 17, 1978
STREP-TEX
K781607 · GTZ
Burroughs Wellcome Co.
Immunology · 29d
Cleared Oct 17, 1978
BACK TRAC
K781647 · HST
Tech Engineering, Inc.
Neurology · 20d
Cleared Oct 17, 1978
TERRY KERATOMETER
K781650 · HJA
Clifford M. Terry, M.C.
Ophthalmic · 20d
Cleared Oct 17, 1978
PROJECTOR, ACCU-CHART ACUITY
K781658 · HOS
Bausch & Lomb, Inc.
Ophthalmic · 19d
Cleared Oct 17, 1978
THERMOMETER, DIGITAL ELEC. MODEL 4755
K781661 · FLL
British Aerospace, Inc.
General Hospital · 18d
Cleared Oct 17, 1978
MAXI-CAMERA 535
K781673 · IYX
General Electric Co.
Radiology · 14d
Cleared Oct 17, 1978
X-RAY STAND, PORTABLE
K781676 · IZL
General X-Ray, Inc.
Radiology · 18d
Cleared Oct 17, 1978
PHIPIOLOGICAL SYNCHRONIZER PART#205
K781681 · IXQ
Brattle Instrument Corp.
Radiology · 15d
Cleared Oct 16, 1978
OXYGEN CONCENTRATOR
K781300 · CAW
Bendix Instruments & Life Support Div
Anesthesiology · 80d