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
92209–92232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1997
MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW
K972117 · LHI
Medical Specialty Innovations, Inc....
General Hospital · 82d
Cleared Aug 26, 1997
BAG DECANTER
K972134 · LHI
Remington Medical, Inc.
General Hospital · 81d
Cleared Aug 26, 1997
MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
K972135 · FPA
P/L Biomedical
General Hospital · 81d
Cleared Aug 26, 1997
DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
K972183 · HSB
Ace Medical Co.
Orthopedic · 77d
Cleared Aug 26, 1997
OSOM MONO TEST 143
K972231 · KTN
Wyntek Diagnostics, Inc.
Immunology · 71d
Cleared Aug 26, 1997
IMTEC BIOBARRIER MEMBRANE
K972240 · NPK
Imtec Corp.
Dental · 71d
Cleared Aug 26, 1997
AURECAST GF
K972319 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 67d
Cleared Aug 26, 1997
INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER
K972356 · MBI
Innovasive Devices, Inc.
Orthopedic · 62d
Cleared Aug 26, 1997
3I INNOVATIVE IMPLANTS AND COVER SCREWS
K972444 · DZE
Implant Innovations, Inc.
Dental · 57d
Cleared Aug 26, 1997
CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
K972503 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 54d
Cleared Aug 26, 1997
SURGICAL BURS AND SURGICAL DRILL BITS
K972508 · HWE
Synvasive Technology, Inc.
Orthopedic · 54d
Cleared Aug 26, 1997
METALPRIMER II
K972594 · KLE
GC America, Inc.
Dental · 46d
Cleared Aug 26, 1997
OPT80 THE TRANSPORTABLE (OPT80)
K972810 · FQO
O.P.T. USA, Inc.
General & Plastic Surgery · 29d
Cleared Aug 26, 1997
AURECAST BIO 59PF
K972939 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 67d
Cleared Aug 26, 1997
AURECAST BIO 69PF
K972940 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 67d
Cleared Aug 26, 1997
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR
K973063 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 8d
Cleared Aug 25, 1997
NITRILE GLOVES
K970135 · LZC
Sage Products, Inc.
General Hospital · 222d
Cleared Aug 25, 1997
SAFARI
K970646 · INI
Ranger All Season Corp.
Physical Medicine · 195d
Cleared Aug 25, 1997
ACCUTEMP-PROBE
K970686 · FMT
Kentec Medical, Inc.
General Hospital · 181d
Cleared Aug 25, 1997
GYREX PRIMA 1TG 1.0T MRI SYSTEM
K970990 · LNH
Elscint Mr, Inc.
Radiology · 160d
Cleared Aug 25, 1997
DASH, SULLIVAN, VITAL GARD
K971044 · LYY
Dash Medical Gloves, Inc.
General Hospital · 157d
Cleared Aug 25, 1997
LAPARETTE
K971146 · KNF
Rd Chus, Inc.
Obstetrics & Gynecology · 150d
Cleared Aug 25, 1997
VIEWCATH 3-D CATHETER PULLBACK
K971397 · ITX
Quinton, Inc.
Radiology · 132d
Cleared Aug 25, 1997
REPICCI II UNICONDYLAR KNEE
K971938 · HRY
Biomet, Inc.
Orthopedic · 90d