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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
103897–103920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1995
MS CLASSIQUE BALLOON CATHETER
K944143 · FGE
Meadox Surgimed, Inc.
Gastroenterology & Urology · 200d
Cleared Mar 13, 1995
ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC)
K944511 · FOZ
Neostar Medical Technologies, Inc.
General Hospital · 179d
Cleared Mar 13, 1995
ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY
K944660 · FOZ
Neostar Medical Technologies, Inc.
General Hospital · 173d
Cleared Mar 13, 1995
OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL
K944943 · DZE
Opti-Max
Dental · 157d
Cleared Mar 13, 1995
FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET
K945396 · DYB
B.Braun Medical, Inc.
Cardiovascular · 130d
Cleared Mar 13, 1995
BEECH PRO LOK FIXED
K946082 · FPA
Beech Medical Products, Inc.
General Hospital · 90d
Cleared Mar 13, 1995
FLUTTER(R)
K946083 · BYI
Bradstreet Clinical Research Assoc.,...
Anesthesiology · 90d
Cleared Mar 13, 1995
SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS
K946204 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 82d
Cleared Mar 13, 1995
CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
K950186 · JHW
Miles, Inc.
Chemistry · 55d
Cleared Mar 13, 1995
E-Z SET(R) AND MINICATH(R) INFUSION SETS
K950302 · FPA
Becton Dickinson Vascular Access, Inc.
General Hospital · 47d
Cleared Mar 13, 1995
COMPA LAB-R
K950765 · EBF
Robert W. Bauer & Assoc., Inc.
Dental · 24d
Cleared Mar 13, 1995
ARGELITE 61 (PALLADIUM - SILVER DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)
K950772 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Mar 10, 1995
SUNDT SLIM-LINE GRAFT CLIPS
K912456 · HCH
Codman & Shurtleff, Inc.
Neurology · 1376d
Cleared Mar 10, 1995
SAFE-STEP
K931517 · IRN
Lenjoy Engineering, Inc.
Physical Medicine · 714d
Cleared Mar 10, 1995
EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM
K933494 · JWH
Exactech, Inc.
Orthopedic · 599d
Cleared Mar 10, 1995
SPINALPLANE
K934336 · HSZ
Synvasive Technology, Inc.
Orthopedic · 549d
Cleared Mar 10, 1995
3002 AEROMAX
K942444 · CAF
Medical Industries America, Inc.
Anesthesiology · 291d
Cleared Mar 10, 1995
STABILITY SYSTEM (110V) MODEL 945-300
K942694 · KHX
Biodex Medical Systems, Inc.
Physical Medicine · 276d
Cleared Mar 10, 1995
PRO-SPORT HEART RATE MONITOR
K943242 · DRT
Sensor Dynamics, Inc.
Cardiovascular · 247d
Cleared Mar 10, 1995
PULSE HEART RATE MONITOR
K943243 · DRT
Sensor Dynamics, Inc.
Cardiovascular · 247d
Cleared Mar 10, 1995
DELFIA NEONATAL THYROXINE KIT
K943416 · CDX
Wallac OY
Chemistry · 238d
Cleared Mar 10, 1995
ABL5 BLOOD GAS SYSTEM
K943882 · CHL
Radiometer America, Inc.
Chemistry · 213d
Cleared Mar 10, 1995
KRDL 2000
K944819 · BXB
Physicians Consulting, Inc.
Physical Medicine · 162d
Cleared Mar 10, 1995
IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)
K944933 · JMF
Diagnostic Products Corp.
Chemistry · 155d