FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
126985–127008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1990
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K893711 · DTN
Shiley, Inc.
Cardiovascular · 286d
Cleared Feb 28, 1990
UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF
K894826 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 212d
Cleared Feb 28, 1990
ACCESSOR PERIPHERAL DILATING GUIDE WIRE
K895179 · LIT
Peripheral Systems Group
Cardiovascular · 202d
Cleared Feb 28, 1990
CATHETER BALLOON DILATOR PRESSURE GAUGE
K895511 · MAV
Argon Medical Corp.
Cardiovascular · 169d
Cleared Feb 28, 1990
AIV SYSTEMS' IV POLES
K895776 · FOX
Automated IV Systems, Inc.
General Hospital · 154d
Cleared Feb 28, 1990
KING OF HEARTS 1200 MONITOR
K896039 · DXH
Instromedix, Inc.
Cardiovascular · 135d
Cleared Feb 28, 1990
TYPE 9290 INTERFACE RESPIRATOR
K896735 · CBK
S & W Medico Teknik
Anesthesiology · 90d
Cleared Feb 28, 1990
TYPE 9291 INTERFACE RESPIRATOR
K896736 · CBK
S & W Medico Teknik
Anesthesiology · 90d
Cleared Feb 28, 1990
TYPE 9292 INTERFACE CAPNOGRAPH
K896737 · CCK
S & W Medico Teknik
Anesthesiology · 90d
Cleared Feb 28, 1990
SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.
K896741 · DQO
Schneider Intl., Ltd.
Cardiovascular · 90d
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