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

Filters: Cleared only ×
176,076 results
162001–162024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 1982
DAKO PAP KIT K505
K812484 · DEW
Dako Corp.
Pathology · 163d
Cleared Feb 10, 1982
DAKO PAP KIT K504
K812485 · DFH
Dako Corp.
Pathology · 163d
Cleared Feb 10, 1982
10D (TENS DEVICE)
K813283 · GZJ
Staodynamics, Inc.
Neurology · 79d
Cleared Feb 10, 1982
KEY MED FOREIGN BODY REMOVAL TUBE
K813325 · FED
Keymed, Inc.
Gastroenterology & Urology · 78d
Cleared Feb 10, 1982
DEVICE FOR REPOSITIONING A BET PATIENT
K813356 · FNJ
Ali-Oop Co., Inc.
General Hospital · 75d
Cleared Feb 10, 1982
FREEZE DRIED FICIN
K813404 · KSK
Biological Corp. of America
Immunology · 65d
Cleared Feb 10, 1982
101 TOTAL CONDYLAR KNEE SYSTEM
K813598 · JWH
Intermedics Orthopedics
Orthopedic · 44d
Cleared Feb 10, 1982
VIT-O-METER
K820032 · BZG
Health Scan, Inc.
Anesthesiology · 35d
Cleared Feb 10, 1982
KEOFEED 500 ENTERIC FEEDING PUMP
K820063 · FRN
Hedeco
General Hospital · 30d
Cleared Feb 10, 1982
OPEN LOOP INFUSION PUMP
K820219 · FRN
Iatric Devices
General Hospital · 15d
Cleared Feb 10, 1982
HOLLISTER FEMALE URINARY COLLECT SYS
K820234 · KNX
Hollister, Inc.
Gastroenterology & Urology · 13d
Cleared Feb 08, 1982
GLAUKON
K812015
Sonometrics Systems, Inc.
Ophthalmic · 206d
Cleared Feb 05, 1982
CHARLES MICRO PROBE
K812857 · HQE
Mid Laboratories, Inc.
Ophthalmic · 115d
Cleared Feb 05, 1982
HUTT SWIVEL WALKER & HUTT STANDING FRAME
K812903
Barnett Medical
Physical Medicine · 112d
Cleared Feb 05, 1982
SOFT PLATE CUSHION
K813190 · EHS
Leonard Russo Co.
Dental · 81d
Cleared Feb 05, 1982
ULTIMATE-AIRE
K813258 · FRF
Hawkins Intl.
General Hospital · 78d
Cleared Feb 05, 1982
BLOOD POOL & SUBVETINAL FLUID ASPIRATOR
K813274 · HQE
Optical Micro Systems, Inc.
Ophthalmic · 74d
Cleared Feb 05, 1982
IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.
K813544 · IYN
Irex Corp.
Radiology · 46d
Cleared Feb 05, 1982
ACKRAD N-DO VAGE TUBE
K813607 · FQH
Ackrad Laboratories
General Hospital · 38d
Cleared Feb 05, 1982
VITRE CON
K820026 · HQE
Medical Instrument Development...
Ophthalmic · 31d
Cleared Feb 05, 1982
HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE
K820030 · HRY
Howmedica Corp.
Orthopedic · 31d
Cleared Feb 05, 1982
TELFA STRIPS
K820056 · NAB
Stan-Pak Ent.
General & Plastic Surgery · 25d
Cleared Feb 05, 1982
AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL
K820079 · BTI
James L. Geraci & Associates, Inc.
Anesthesiology · 24d
Cleared Feb 05, 1982
COMBINE PAD OR ABD
K820105 · NAB
Stan-Pak Ent.
General & Plastic Surgery · 21d