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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
137689–137712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 1988
PT PRO-CLOT
K874373 · JBR
Probe-Tek, Inc.
Hematology · 71d
Cleared Jan 05, 1988
REAGENT A AND REAGENT B
K874413 · JIX
Seradyn, Inc.
Chemistry · 69d
Cleared Jan 05, 1988
QBC SYSTEM HEMOGLOBIN
K874427 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 69d
Cleared Jan 05, 1988
FLUID SAMPLING PACK
K874436 · KSS
U.S. Mfg. & Management, Inc.
Hematology · 69d
Cleared Jan 05, 1988
BLOOD UREA NITROGEN
K874532 · CDW
Catachem, Inc.
Chemistry · 63d
Cleared Jan 05, 1988
PARAMAX URINE/CSF CALIBRATOR
K874587 · JIX
Baxter Healthcare Corp
Chemistry · 57d
Cleared Jan 05, 1988
REVISED LABELING FOR SYVA BARBITURATE ASSAYS
K874702 · DIS
Syva Co.
Toxicology · 50d
Cleared Jan 05, 1988
REFLOTRON (R) AMYLASE
K874704 · JFJ
Boehringer Mannheim Corp.
Chemistry · 47d
Cleared Jan 05, 1988
DC-TROL LEVEL 1 OR 2
K874772 · JJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 47d
Cleared Jan 05, 1988
REFERENCE ASSAYED CHEMISTRY CONTROL SERUM
K874810 · JJY
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Jan 05, 1988
PROSPECT/GIARDIA
K874849 · KHW
Alexon Biomedical, Inc.
Microbiology · 41d
Cleared Jan 05, 1988
EMIT CONVENIENCE PACK: PHENYTOIN ASSAY
K874856 · DIP
Syva Co.
Toxicology · 41d
Cleared Jan 05, 1988
SAKURA DRS-60 AUTOMATIC SLIDE STAINER
K874897 · KPA
Sakura Finetek U.S.A., Inc.
Pathology · 35d
Cleared Jan 05, 1988
MUG-INDOLE DISC
K874933 · JTO
Scott Laboratories, Inc.
Microbiology · 32d
Cleared Jan 05, 1988
BIOTROL BICARBONATE (CO2) UV HP)
K874941 · KHS
Biotrol, USA, Inc.
Chemistry · 34d
Cleared Jan 04, 1988
ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.
K872265 · HGL
Labsonics, Inc.
Obstetrics & Gynecology · 207d
Cleared Jan 04, 1988
MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR
K874076 · IPF
Physio Technology, Inc.
Physical Medicine · 90d
Cleared Jan 04, 1988
ENDOSCOPES FOR SINUS SURGERY
K874215 · EOB
Richards Medical Co., Inc.
Ear, Nose, Throat · 80d
Cleared Jan 04, 1988
VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF
K874367 · HQO
Spembly Medical , Ltd.
Ophthalmic · 73d
Cleared Jan 04, 1988
NEEDLE CONTAINER
K874430 · FMI
American Medical Technology, Inc.
General Hospital · 68d
Cleared Jan 04, 1988
MODIFIED SIMPSON PERIPHERAL ATHEROCATH
K874706 · LIT
Devices For Vascular Intervention, Inc.
Cardiovascular · 61d
Cleared Jan 04, 1988
KODAK REMOTE ALARM UNIT
K874926 · IXW
Eastman Kodak Company
Radiology · 33d
Cleared Jan 04, 1988
TUNING FORKS
K874966 · GWX
Solway, Inc.
Neurology · 33d
Cleared Dec 31, 1987
SOKEN(TM) ELECTRONIC MUSCLE STIMULATOR
K873125 · IPF
Rehab Medical Specialties, Inc.
Physical Medicine · 143d