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
129001–129024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1989
EYE PATCH
K896171 · HOY
Eye Garter Company, Inc.
Ophthalmic · 9d
Cleared Nov 03, 1989
STRAPPED EYE SHIELD
K896172 · HOY
Eye Garter Company, Inc.
Ophthalmic · 9d
Cleared Nov 02, 1989
BARD LIBERATOR DISPOSABLE INFUSION SYSTEM
K894292 · FRN
C.R. Bard, Inc.
General Hospital · 132d
Cleared Nov 02, 1989
BACTERIAL FILTER
K894978 · CAH
Med-Tek Corp.
General Hospital · 91d
Cleared Nov 02, 1989
BIO-CAL 370 HEATER/COOLER
K894980 · DWJ
Bio Medicus, Inc.
Cardiovascular · 86d
Cleared Nov 02, 1989
MODIFIED POSICAM SYSTEM MODEL 6.5
K894998 · KPS
Positron
Radiology · 86d
Cleared Nov 02, 1989
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K895253 · BZG
Welch Allyn, Inc.
Anesthesiology · 73d
Cleared Nov 02, 1989
COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
K895342 · LZU
Lacrimedics, Inc.
Ophthalmic · 63d
Cleared Nov 02, 1989
PUPIL PATHWAY ANALYZER (PPA)
K895609 · HLG
Pulse Medical Instruments
Ophthalmic · 45d
Cleared Nov 02, 1989
MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL
K895819 · KMF
Medi-Tech, Inc.
General & Plastic Surgery · 34d
Cleared Nov 02, 1989
ALCON SURGICAL SPONGE
K896004 · HOZ
Alcon Laboratories
Ophthalmic · 20d
Cleared Nov 02, 1989
MICROSPEARS
K896084 · HOZ
Sparta Surgical Corp.
Ophthalmic · 14d
Cleared Nov 01, 1989
BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES
K892641 · DTZ
Bard Cardiosurgery Div
Cardiovascular · 203d
Cleared Nov 01, 1989
OPTICALLY CLEAR RADIOPAQUE CATHETER
K893546 · FOZ
Critikon Company, LLC
General Hospital · 174d
Cleared Nov 01, 1989
LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE
K893766 · MAJ
Abbott Laboratories
General Hospital · 166d
Cleared Nov 01, 1989
NANOS
K894239 · DXY
Biotronik Cardiac Pacemakers
Cardiovascular · 134d
Cleared Nov 01, 1989
DATASCOPE STEERING HANDLE
K894940 · DQX
Datascope Corp.
Cardiovascular · 90d
Cleared Nov 01, 1989
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
K894970 · DTZ
Minntech Corp.
Cardiovascular · 86d
Cleared Nov 01, 1989
PIK POCKET(R), MODEL PP-3
K895259 · EFS
Teledyne Water Pik
Dental · 152d
Cleared Nov 01, 1989
FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE
K895320 · LLZ
Digivision, Inc.
Radiology · 64d
Cleared Nov 01, 1989
MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES
K895457 · KNW
Advance Medical Designs, Inc.
Gastroenterology & Urology · 57d
Cleared Nov 01, 1989
2018 ARTERIAL/VENOUS PRESSURE DRESSING
K895845 · NAD
Advance Medical Designs, Inc.
General & Plastic Surgery · 29d
Cleared Oct 31, 1989
FATIGMETER
K883914 · GWE
K. Jimbo Co., Inc.
Neurology · 410d
Cleared Oct 31, 1989
HEDY PATIENT EXAMINATION GLOVES (VINYL)
K891670 · LYZ
Hedd Industry Corp.
General Hospital · 225d