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
106873–106896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1994
THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR
K941026 · BZA
Thayer Medical Corp.
Anesthesiology · 167d
Cleared Aug 18, 1994
BNOS MICRO VENT, MODEL AC AND MODEL AO
K941037 · BTM
Reeves Manufactoring
Anesthesiology · 169d
Cleared Aug 18, 1994
SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL
K941227 · KCW
Instantron
General & Plastic Surgery · 163d
Cleared Aug 18, 1994
TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2
K941328 · JJY
Medical Analysis Systems, Inc.
Chemistry · 153d
Cleared Aug 18, 1994
AXSYM TOBRAMYCIN
K941614 · LFW
Abbott Laboratories
Toxicology · 136d
Cleared Aug 18, 1994
SEALITE SCIENCES INC.
K941983 · DHA
Sealite Sciences, Inc.
Chemistry · 115d
Cleared Aug 18, 1994
SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY...
K942154 · LIT
Boston Scientific Scimed, Inc.
Cardiovascular · 125d
Cleared Aug 18, 1994
DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN
K942241 · JKA
Dupont Medical Products
Chemistry · 101d
Cleared Aug 18, 1994
ESOPHAGEAL INTUBATION DETECTOR BULB
K942628 · BTR
Wolfe Tory Medical, Inc.
Anesthesiology · 77d
Cleared Aug 18, 1994
NCE REPLACEMENT BATTERIES
K942629 · DPS
National Custom Ent., Inc.
Cardiovascular · 76d
Cleared Aug 18, 1994
PROCEL BURN COVER/PROCEL BURN TREATMENT COVER
K943280 · MGP
W.L. Gore & Company, GmbH
General & Plastic Surgery · 42d
Cleared Aug 18, 1994
ESOPHAGOSCOPE AND ACCESSORIES
K943667 · EOX
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 21d
Cleared Aug 18, 1994
MO6 SERIES
K943670 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 23d
Cleared Aug 17, 1994
POWDERFREE LATEX EXAMINATION GLOVES
K933288 · LYY
Liwe Trading
General Hospital · 407d
Cleared Aug 17, 1994
CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT
K933320 · IYO
Cardio Metrics, Inc.
Radiology · 406d
Cleared Aug 17, 1994
RADWORKS
K934645 · EAP
Radworks Corp.
Radiology · 330d
Cleared Aug 17, 1994
B-D DIGITAL THERMOMETER
K935267 · FLL
Bd Becton Dickinson Vacutainer...
General Hospital · 288d
Cleared Aug 17, 1994
LAPAROSCOPES
K936195 · GCJ
Micromedical Devices, Inc.
General & Plastic Surgery · 231d
Cleared Aug 17, 1994
CARDIO REP LD
K940224 · CFE
Helena Laboratories
Chemistry · 211d
Cleared Aug 17, 1994
AMERICAN CATHETER E.R.C.P. CANNULA
K940370 · FGE
Intl. Medical, Inc.
Gastroenterology & Urology · 203d
Cleared Aug 17, 1994
KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP
K940386 · IXL
Eastman Kodak Company
Radiology · 203d
Cleared Aug 17, 1994
COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH
K940550 · IWJ
Cook, Inc.
Radiology · 191d
Cleared Aug 17, 1994
DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR
K940769 · DYN
Terraflex
Dental · 180d
Cleared Aug 17, 1994
FLOWGUN ELECTROCAUTERY PROBES
K941337 · GEI
O.R. Concepts, Inc.
General & Plastic Surgery · 149d