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
164737–164760 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1981
KNEE PROSTHESIS
K810540 · HRY
Cintor Orthopaedic Div.
Orthopedic · 39d
Cleared Apr 07, 1981
MOBILE MATIC AUTOMATIC DONOR SCALE
K810617 · KSQ
Lifeline Instruments, Inc.
Hematology · 29d
Cleared Apr 07, 1981
HOLLISTER SKIN BARRIER A
K810709 · EXB
Hollister, Inc.
Gastroenterology & Urology · 21d
Cleared Apr 07, 1981
HOLLISTER SKIN BARRIER B
K810710 · EXB
Hollister, Inc.
Gastroenterology & Urology · 21d
Cleared Apr 07, 1981
TECHNICON STAR SYSTEM T3 RIA METHOD
K810798 · CDP
Technicon Instruments Corp.
Chemistry · 15d
Cleared Apr 07, 1981
HOLLISEAL OSTOMY SKIN BARRIER
K810807 · EXB
Hollister, Inc.
Gastroenterology & Urology · 14d
Cleared Apr 07, 1981
T4 RIA KIT
K810811 · CDX
Immuno Assay Corp.
Chemistry · 14d
Cleared Apr 07, 1981
PREFILLED ARTERIAL BLOOD SAMPLING SYRING
K810816 · JKA
Current Technologies, Inc.
Hematology · 14d
Cleared Apr 06, 1981
SURU INFUSION SET TYPE J
K802169 · FPA
Suru Chemicals & Pharmaceuticals, Ltd.
General Hospital · 210d
Cleared Apr 06, 1981
SURU BLOOD COLLECTION SET
K802170 · FPA
Suru Chemicals & Pharmaceuticals, Ltd.
General Hospital · 210d
Cleared Apr 03, 1981
SERIES 810 PLATELET ANALYZER
K803128 · GKL
J.T. Baker Chemical Co.
Hematology · 112d
Cleared Apr 03, 1981
FASHION SUNGLASSES
K803308 · HQY
Grand Imperial, Inc.
Ophthalmic · 94d
Cleared Apr 03, 1981
SYNAP-I INFANT SENSORY ASSESSMENT UNIT
K810138 · GWJ
Infant Hearing Assessment Foundation
Neurology · 72d
Cleared Apr 03, 1981
PROGRAMMABLE SPINAL CORAL STIM. SYSTEM
K810182 · GZB
Electronic Diagnostics, Inc.
Neurology · 71d
Cleared Apr 03, 1981
EYEGLASS FRAMES
K810278 · HQZ
Caesar Intl. Designs
Ophthalmic · 60d
Cleared Apr 03, 1981
FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE
K810503 · NWS
Olympus Corp.
Gastroenterology & Urology · 38d
Cleared Apr 03, 1981
RICH-MAR HV II SELECT-A-PULSE
K810526 · IMG
Rich-Mar Corp.
Physical Medicine · 36d
Cleared Apr 03, 1981
EMIT-ST SERUM BARBITURATE ASSAY
K810602 · DIS
Syva Co.
Toxicology · 28d
Cleared Apr 03, 1981
ANTIMICROBIAL REMOVAL DEVICE
K810613 · MDB
Marion Laboratories, Inc.
Microbiology · 28d
Cleared Apr 03, 1981
ELECTROSURGICAL CUTTING & COAGULATION
K810628 · JOS
Intermedics, Inc.
General & Plastic Surgery · 25d
Cleared Apr 03, 1981
SHILEY OXYGENATOR THERMISTOR PROBE
K810647 · DWC
Shiley, Inc.
Cardiovascular · 23d
Cleared Apr 03, 1981
PENTAX COLONOSCOPE MODEL FC-34LA
K810682 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 21d
Cleared Apr 03, 1981
I.M. SCALPEL HANDLE
K810720 · GDZ
Instrument Makar, Inc.
General & Plastic Surgery · 17d
Cleared Apr 03, 1981
TAB PEDIATRIC CRIB
K810728 · FMS
Cambridge Scientific
General Hospital · 17d