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
142465–142488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1986
MODEL 1010 AMBULATORY PH MONITORING SYSTEM
K862536 · FFT
Oxford Medilog, Inc.
Gastroenterology & Urology · 72d
Cleared Sep 12, 1986
FUNS-10, FUNS-11
K862551 · FGB
Reichert-Jung, Inc.
Gastroenterology & Urology · 71d
Cleared Sep 12, 1986
OHMEDA 5410 VOLUME MONITOR
K862687 · BZK
Ohmeda Medical
Anesthesiology · 59d
Cleared Sep 12, 1986
OHMEDA 5420 VOLUME MONITOR
K862688 · BZK
Ohmeda Medical
Anesthesiology · 59d
Cleared Sep 12, 1986
STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE
K862836 · DXS
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 12, 1986
LASER ASSISTED SURGICAL LAPAROSCOPY KITS
K863241
Lifestream Int'L, Inc.
General & Plastic Surgery · 21d
Cleared Sep 12, 1986
CORDIPAK ANGIOGRAPHY TRAY
K863336
Angi-Pak Corp.
General & Plastic Surgery · 15d
Cleared Sep 12, 1986
NEOMED NON GEL-R TOTAL ADHESIVE CONDUCT. ELECTRODE
K863360 · GEI
Richards Medical Co., Inc.
General & Plastic Surgery · 10d
Cleared Sep 12, 1986
CONCEPT INTRAVISION ARTHROSCOPE SYSTEM
K863396 · HRX
Concept, Inc.
Orthopedic · 9d
Cleared Sep 11, 1986
PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR
K862107 · ODC
Penn Medical Devices, Inc.
Gastroenterology & Urology · 100d
Cleared Sep 11, 1986
TOXONOSTIKA IGM MICROELISA SYSTEM
K862196 · LGD
Organon Teknika Corp.
Microbiology · 94d
Cleared Sep 11, 1986
ACS HI-TORQUE FLEX-T GUIDE WIRE
K862360 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 80d
Cleared Sep 11, 1986
PULSE OXIMETER
K862426 · DPZ
Draeger Medical, Inc.
Anesthesiology · 77d
Cleared Sep 11, 1986
GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL
K862642 · LQM
American Micro Scan
Microbiology · 62d
Cleared Sep 11, 1986
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER
K862673 · DQO
Medtronic Vascular
Cardiovascular · 59d
Cleared Sep 11, 1986
ALBUMETER
K863050 · CIX
J. D. Assoc.
Chemistry · 30d
Cleared Sep 11, 1986
CHOLESTEROL-E (FREE)
K863064 · CHH
J. D. Assoc.
Chemistry · 30d
Cleared Sep 11, 1986
FAST MUCOPROTEINS
K863070 · JQN
J. D. Assoc.
Chemistry · 30d
Cleared Sep 11, 1986
CHOLINESTERASE
K863111 · DIH
J. D. Assoc.
Toxicology · 29d
Cleared Sep 11, 1986
HEALTHCHECK THERM-STRIP
K863181 · FQZ
Healthcheck Corp.
General Hospital · 23d
Cleared Sep 11, 1986
INORGANIC PHOSPHORUS PROCEDURE
K863264 · CEO
Data Medical Associates, Inc.
Chemistry · 17d
Cleared Sep 11, 1986
IRON PROCEDURE
K863266 · JIY
Data Medical Associates, Inc.
Chemistry · 17d
Cleared Sep 11, 1986
MAGNESIUM PROCEDURE
K863267 · CFA
Data Medical Associates, Inc.
Chemistry · 17d
Cleared Sep 11, 1986
INFUSE-A-PORT EXPLANT KIT
K863296 · LJT
Intermedics/Infusaid, Inc.
General Hospital · 17d