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
164041–164064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1981
ANKLE-FOOT CAST/SPLINT
K811690 · IQI
Surgical Appliance Industries, Inc.
Physical Medicine · 10d
Cleared Jun 24, 1981
CASTLE STEAM STERILIZATION INDICATOR
K810614 · JOJ
Sybron Corp.
General Hospital · 107d
Cleared Jun 24, 1981
FORECASTER
K810832 · LHD
Forecaster Co.
Obstetrics & Gynecology · 91d
Cleared Jun 24, 1981
CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS
K810999 · KLK
Cordis Corp.
Anesthesiology · 72d
Cleared Jun 24, 1981
HUMIDIFIER W/ OR W/OUT ADAPTOR
K811161 · KFZ
Airlife, Inc.
Anesthesiology · 57d
Cleared Jun 24, 1981
EFTEKHAR CENTRALIZING PLUG
K811293 · JDI
Zimmer, Inc.
Orthopedic · 44d
Cleared Jun 24, 1981
N-TERMINAL HPTH BY RIA
K811418 · CEW
Immuno Nuclear Corp.
Chemistry · 36d
Cleared Jun 24, 1981
KALLESTAD R QUANTIPLATE ALT. PATHWAY T.
K811445 · DHL
Kallestad Laboratories, Inc.
Immunology · 33d
Cleared Jun 24, 1981
BACILLUS CEREUS SELECTIVE(AGAR&SUPP)
K811514 · JSI
Oxoid U.S.A., Inc.
Toxicology · 27d
Cleared Jun 24, 1981
THIOGLYCOLLATE MED. W/OUT INDICATOR
K811515 · JSG
Oxoid U.S.A., Inc.
Toxicology · 27d
Cleared Jun 24, 1981
LEGIONELLA, GROWTH & SELECTIVE, SUPP.
K811516 · JSK
Oxoid U.S.A., Inc.
Toxicology · 27d
Cleared Jun 24, 1981
VCN SUPPLEMENT
K811517 · JSK
Oxoid U.S.A., Inc.
Toxicology · 27d
Cleared Jun 24, 1981
VCNT ANTIBIOTIC SUPPLEMENT
K811518 · JSK
Oxoid U.S.A., Inc.
Toxicology · 27d
Cleared Jun 24, 1981
KALLESTAD QUANTITOPE LOW LEVEL IGE REAG
K811545 · DGC
Kallestad Laboratories, Inc.
Chemistry · 23d
Cleared Jun 23, 1981
AUTOMATED GASTRIC LAVAGE
K811061 · KNT
Emergency Medicine
Gastroenterology & Urology · 67d
Cleared Jun 23, 1981
X-CELL X-RAY #'S P-75W/P-75M
K811230 · KPR
X-Cel X-Ray Corp.
Radiology · 50d
Cleared Jun 23, 1981
CRYOPHTHALMIC UNIT
K811244 · HRS
Keeler Instruments, Inc.
Orthopedic · 50d
Cleared Jun 23, 1981
DIGITAL NOISE REDUCER
K811295 · JAA
Philips Medical Systems (Cleveland),...
Radiology · 43d
Cleared Jun 23, 1981
SOMATOM 2N
K811302 · IZF
Siemens Corp.
Radiology · 43d
Cleared Jun 23, 1981
MODEL DM-333 DIALYSIS CONTROL STATION
K811444 · FKQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 32d
Cleared Jun 23, 1981
MODEL RS-8100
K811457 · KOC
Rinal Systems, Inc.
Gastroenterology & Urology · 32d
Cleared Jun 23, 1981
MODEL FUS-1, FLEXIBLE URETEROSCOPE
K811535 · FGB
American Optical Corp.
Gastroenterology & Urology · 22d
Cleared Jun 23, 1981
CERVICAL SPATULA
K811548 · HHT
Procedure Products, Inc.
Obstetrics & Gynecology · 22d
Cleared Jun 19, 1981
7.5 MHZ WP TRANSDUCER
K810748 · ITX
General Electric Co.
Radiology · 91d