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
163969–163992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1981
PENTAX COLONOSCOPE MODEL FC-34 MA
K810791 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 8d
Cleared Mar 30, 1981
LITRONIC STIMULATOR
K810225 · IPF
Med-Western Electronics, Inc.
Physical Medicine · 62d
Cleared Mar 30, 1981
DRESSING CHANGE TRAY-MEDIUM
K810570 · LDQ
Associated Medical Products Co.
General & Plastic Surgery · 27d
Cleared Mar 27, 1981
GANZ CORONARY REPERFUSION CATHETER
K803270 · DQO
American Edwards Laboratories
Cardiovascular · 88d
Cleared Mar 27, 1981
TERFUSION FINAL FILTER SET
K810113 · FPB
Terumo Medical Corp.
General Hospital · 80d
Cleared Mar 27, 1981
17B ESTRADIOL
K810204 · CHP
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 60d
Cleared Mar 27, 1981
SWAN-GANZ FLOW-DIRECTED THERMODILUTION
K810352 · DYG
American Edwards Laboratories
Cardiovascular · 45d
Cleared Mar 27, 1981
710 FLUOROMETER/DENSITOMETER
K810619 · JQT
Corning Medical & Scientific
Chemistry · 18d
Cleared Mar 27, 1981
HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-
K810625 · DHI
Serono Laboratories, Inc.
Chemistry · 18d
Cleared Mar 27, 1981
DPM CALCULATOR
K810631 · JQP
Iso-Data, Inc.
Chemistry · 17d
Cleared Mar 27, 1981
VINYL ICE BAG
K810653 · KYR
First Industries, Inc.
General Hospital · 17d
Cleared Mar 27, 1981
STOPPERLESS HOT/COLD RUBBER WATER BOTTLE
K810654 · FDF
First Industries, Inc.
Gastroenterology & Urology · 17d
Cleared Mar 27, 1981
CATHDAMP
K810661 · DRS
Medline Industries, Inc.
Cardiovascular · 16d
Cleared Mar 27, 1981
LEECO FSH-QUANT DIAGNOSTIC KIT
K810663 · CGJ
Leeco Diagnostics, Inc.
Chemistry · 16d
Cleared Mar 27, 1981
ARROW RADIAL ARTERY CATHETERIZATION SET
K810675 · DQX
Arrow Intl., Inc.
Cardiovascular · 15d
Cleared Mar 27, 1981
PHYSIOLOGIC RECORDER
K810696 · DPS
Honeywell, Inc.
Cardiovascular · 11d
Cleared Mar 27, 1981
MODEL SP5107 THERMODILUTION CATHETER
K810730 · KRB
Gould, Inc.
Cardiovascular · 10d
Cleared Mar 27, 1981
MODEL IM1000 INTEGRATED MONITOR
K810731 · DQK
Gould, Inc.
Cardiovascular · 10d
Cleared Mar 27, 1981
LINDE MARK II OXYGEN RESERV. TYPE OR-4
K810732 · BYJ
Union Carbide Corp.
Anesthesiology · 10d
Cleared Mar 27, 1981
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
K810750 · DQK
General Electric Co.
Cardiovascular · 7d
Cleared Mar 27, 1981
OHIO DISPOSABLE TRACHEAL TUBE
K810763 · BTR
Airco/Ohio Medical Products
Anesthesiology · 4d
Cleared Mar 26, 1981
DATAMEDIX PECGASYS SYSTEM
K810027 · DSI
Datamedix
Cardiovascular · 80d
Cleared Mar 26, 1981
VECAFIX*
K810050 · KGX
Pollak (Intl.), Ltd.
General & Plastic Surgery · 72d
Cleared Mar 26, 1981
VASCULAR ACCESS SYSTEM
K810114 · FIQ
Bentley Laboratories, Inc.
Gastroenterology & Urology · 101d