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
93817–93840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1997
CBC-4K HEMATOLOGY CONTROL
K970331 · JPK
R&D Systems, Inc.
Hematology · 78d
Cleared Apr 16, 1997
PROXIDERM (D-460,D 90 460,D 180,460, PS 460)
K970439 · MKY
Progressive Surgical Products, Inc.
General & Plastic Surgery · 70d
Cleared Apr 16, 1997
FOUNDATION INDIRECT COMPOSITE RESIN
K970495 · EBF
Sybron Dental Specialties, Inc.
Dental · 65d
Cleared Apr 16, 1997
STATNET
K970525 · IZI
Gorca Systems, Inc.
Radiology · 64d
Cleared Apr 16, 1997
700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES
K970719 · MKJ
Cardiotronics Systems, Inc.
Cardiovascular · 48d
Cleared Apr 16, 1997
HEIDELBERG EXTERNAL FIXATOR
K970751 · JDW
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 44d
Cleared Apr 16, 1997
PRECISE
K970827 · EJH
Allan Schulman,D.D.S., M.S.
Dental · 41d
Cleared Apr 16, 1997
HANAULUX BLUE 80 HOSPITAL
K970886 · FSS
Heraeus Med GmbH
General & Plastic Surgery · 69d
Cleared Apr 16, 1997
SLIPPERY GLASS
K970941 · EIH
Jeneric/Pentron, Inc.
Dental · 34d
Cleared Apr 16, 1997
CABLE HOLDER, SUCTION TUBE HOLDER
K971040 · GEI
Contour Fabricators, Inc.
General & Plastic Surgery · 26d
Cleared Apr 15, 1997
EGS4000
K955666 · IPF
S&P Electrical Industries, Inc.
Physical Medicine · 489d
Cleared Apr 15, 1997
CONTINUOUS FLUSH DEVICE
K962129 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 316d
Cleared Apr 15, 1997
HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT...
K964382 · CAH
Gibeck, Inc.
General Hospital · 162d
Cleared Apr 15, 1997
EXL-12SP,12DP,15DP,20DP LINAC
K970137 · IYE
Mitsubishi Electronics America, Inc.
Radiology · 90d
Cleared Apr 15, 1997
ROLL AID
K970164 · ITI
Stand Aid of Iowa, Inc.
Physical Medicine · 89d
Cleared Apr 15, 1997
COMPRESSOR/NEBULIZER #3650
K970289 · CAF
Devilbiss Health Care, Inc.
Anesthesiology · 81d
Cleared Apr 15, 1997
MODEL 1100 COLD THERAPY DEVICE
K970533 · ILO
Smith & Nephew, Inc.
Physical Medicine · 62d
Cleared Apr 15, 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
K970602 · KPI
Hollister, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 15, 1997
STEALTHSHIELD
K970755 · DRX
Vital Connections, Inc.
Cardiovascular · 43d
Cleared Apr 15, 1997
E-TYPE SPEED REDUCER CONTRA ANGLE
K970953 · KMW
Nsk Nakanishi, Inc.
Dental · 29d
Cleared Apr 15, 1997
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
K971192 · DSY
Impra, Inc.
Cardiovascular · 15d
Cleared Apr 14, 1997
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K962814 · KPM
Denver Biomaterials, Inc.
Gastroenterology & Urology · 269d
Cleared Apr 14, 1997
SNORE TEC
K963063 · LRK
Marketing Technologies, Inc.
Dental · 250d
Cleared Apr 14, 1997
HERRICK ULTIMATE PUNCTUM PLUG
K963501 · LZU
Lacrimedics, Inc.
Ophthalmic · 223d