FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
131977–132000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 1989
COATED ISOLATION GOWN
K891677 · FYC
Durante Intl., Inc.
General Hospital · 30d
Cleared Apr 20, 1989
NON-STERILE MASKS AND CAPS
K892118 · FYA
Paramount Products, Inc.
General Hospital · 21d
Cleared Apr 19, 1989
UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM
K883969 · HRY
Intermedics Orthopedics
Orthopedic · 211d
Cleared Apr 19, 1989
EXCEL Y-CONNECTOR CAT. #E-201
K884327 · LIT
Medical Profiles, Inc.
Cardiovascular · 187d
Cleared Apr 19, 1989
HEPARIN BONDING FOR CATHETERS
K884697 · DTB
Daig Corp.
Cardiovascular · 161d
Cleared Apr 19, 1989
VITAL SIGNS MONITOR
K884938 · DSK
Tico Medical Instruments, Inc.
Cardiovascular · 142d
Cleared Apr 19, 1989
POROUS COATED GENESIS FEMORAL COMPONENT
K885036 · JWH
Richards Medical Co., Inc.
Orthopedic · 135d
Cleared Apr 19, 1989
SYSTEM SEVENTY SEVEN
K885054 · IYX
Scinticor, Inc.
Radiology · 133d
Cleared Apr 19, 1989
OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT
K885201 · ETA
Microbio-Medics, Inc.
Ear, Nose, Throat · 124d
Cleared Apr 19, 1989
HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)
K885204 · DSI
Mennen Medical, Inc.
Cardiovascular · 121d
Cleared Apr 19, 1989
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
K890282 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Apr 19, 1989
PROSTHETIC CEMENT REMOVER
K890285 · LZV
Albert K. Chin
Orthopedic · 90d
Cleared Apr 19, 1989
MEDILOG EDITOR
K890338 · DSI
Oxford Medilog, Inc.
Cardiovascular · 86d
Cleared Apr 19, 1989
NEOTECH MUCUS TRAP W/CATHETER
K890425 · BSY
Neotech Products, Inc.
Anesthesiology · 83d
Cleared Apr 19, 1989
LIPID STOPCOCK
K890580 · DTL
North American Instrument Corp.
Cardiovascular · 72d
Cleared Apr 19, 1989
PHOTOCHROMIC LENS
K890725 · HQY
Ppg Industries, Inc.
Ophthalmic · 65d
Cleared Apr 19, 1989
COATED APEX PROBE
K890735 · LQY
Analytic Technology
Dental · 65d
Cleared Apr 19, 1989
TITANIUM STAPLES
K890841 · GDW
Ethicon, Inc.
General & Plastic Surgery · 57d
Cleared Apr 19, 1989
CD TELEMETRY SYSTEMS
K891104 · DRG
Marquette Electronics, Inc.
Cardiovascular · 48d
Cleared Apr 19, 1989
NOSEY SHADES (SUNGLASSES) NONPRESCRIPTION
K891597 · HQY
Creative Images, Inc.
Ophthalmic · 30d
Cleared Apr 19, 1989
KINETIC MODEL 500
K891756 · FSY
Kinetic Biomedical Services, Inc.
General & Plastic Surgery · 27d
Cleared Apr 19, 1989
KINETIC MODEL 1000
K891757 · FSY
Kinetic Biomedical Services, Inc.
General & Plastic Surgery · 27d
Cleared Apr 19, 1989
KINETIC MODEL 132
K891758 · FSS
Kinetic Biomedical Services, Inc.
General & Plastic Surgery · 27d
Cleared Apr 19, 1989
KINETIC MODEL 330
K891759 · FSS
Kinetic Biomedical Services, Inc.
General & Plastic Surgery · 27d