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
127585–127608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1990
ACS INDEFLATOR XX
K896849 · MAV
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Feb 28, 1990
CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE
K896978 · DTZ
Medtronic Vascular
Cardiovascular · 77d
Cleared Feb 28, 1990
CONFEES(R)+ CONTACT LENS HOLDER
K897084 · LRX
Magnivision, Inc.
Ophthalmic · 70d
Cleared Feb 28, 1990
COMFEES(R) + CON-PAK(TM) LENS CASE
K897085 · LRX
Magnivision, Inc.
Ophthalmic · 70d
Cleared Feb 28, 1990
NEEDLE-SHIELD
K900282 · FMI
Macbrud Corp. Medical Div.
General Hospital · 38d
Cleared Feb 28, 1990
DISCO SUNGLASSES (NON-PRESCRIPTION)
K900387 · HQY
Le-I Electronic Co. , Ltd.
Ophthalmic · 30d
Cleared Feb 28, 1990
IV BIFURCATED EXTENSION SET
K900426 · FPA
Marquette Medical, Inc.
General Hospital · 29d
Cleared Feb 28, 1990
IV TRIFURCATED EXTENSION SET
K900427 · FPA
Marquette Medical, Inc.
General Hospital · 29d
Cleared Feb 27, 1990
LATEX SURGICAL GLOVES
K890019 · LYZ
Argos S.A.
General Hospital · 419d
Cleared Feb 27, 1990
CONVERTER SYSTEM
K894248 · HQE
Mira, Inc.
Ophthalmic · 251d
Cleared Feb 27, 1990
OPTIKEM PMMA CONTACT LENS
K895411 · HPX
Optikem Polymers, Inc.
Ophthalmic · 174d
Cleared Feb 27, 1990
TECNOL LAZER(TM) SURGICAL MASK
K896193 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 125d
Cleared Feb 27, 1990
COBAS READY TOTAL BILIRUBIN REAGENT
K896232 · CIG
Roche Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Feb 27, 1990
COBAS READY ALBUMIN REAGENT
K896235 · CIX
Roche Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Feb 27, 1990
COBAS READY BUN REAGENT
K896236 · JGZ
Roche Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Feb 27, 1990
CMV IGM ELISA TEST SYSTEM
K896355 · LFZ
Zeus Scientific, Inc.
Microbiology · 113d
Cleared Feb 27, 1990
KEY VASCULAR LOOPS
K896676 · KDC
Key Surgical, Inc.
General & Plastic Surgery · 92d
Cleared Feb 27, 1990
RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE
K896777 · DWF
Research Medical, Inc.
Cardiovascular · 88d
Cleared Feb 27, 1990
RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE
K896778 · DWF
Research Medical, Inc.
Cardiovascular · 88d
Cleared Feb 27, 1990
QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3
K896956 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 75d
Cleared Feb 27, 1990
SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM
K897110 · CEM
Medisense, Inc.
Chemistry · 63d
Cleared Feb 27, 1990
CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3
K900004 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 56d
Cleared Feb 27, 1990
CATHETER ADAPTER SEALING CAP NO. 48-1028-9
K900006 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 56d
Cleared Feb 27, 1990
MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*
K900129 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 55d