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
161353–161376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1982
MOD. 587 BLOOD PRESSURE & PULSE MONITOR
K813556 · DXN
Bio Mega Diagnostic, Inc.
Cardiovascular · 31d
Cleared Jan 22, 1982
RADIATION STERILIZED SURGEON'S GLOVES
K813565 · KGO
Travenol Laboratories, S.A.
General Hospital · 31d
Cleared Jan 22, 1982
SIEMENS-ELEMA PULSE GENERATOR 659
K813576 · DXY
Siemens Elema AB
Cardiovascular · 30d
Cleared Jan 22, 1982
TDX PRIMIDONE
K813597 · DJD
Abbott Laboratories
Chemistry · 25d
Cleared Jan 22, 1982
101-32 FEMORAL COMPONENT
K813599 · JDL
Intermedics Orthopedics
Orthopedic · 25d
Cleared Jan 22, 1982
AUFRANC-TURNER TYPE ACETABULAR COMPON
K813600 · JDI
Intermedics Orthopedics
Orthopedic · 25d
Cleared Jan 22, 1982
POTASSIUM REAGENT SET
K813608 · CEJ
Diagnostic Specialties
Chemistry · 24d
Cleared Jan 22, 1982
TEKNA MED MYRINGOTOMY DISPOS-OTO KIT
K813616 · ETD
Humboldt Products
Ear, Nose, Throat · 24d
Cleared Jan 22, 1982
INDEFLATOR
K813622 · DQO
Advanced Catheter Systems
Cardiovascular · 24d
Cleared Jan 22, 1982
SIMPSON-ROBERT CORONARY GUIDING CATHET
K813623 · DQO
Advanced Catheter Systems
Cardiovascular · 24d
Cleared Jan 22, 1982
ADVANCED CATHETER SYSTEMS CORONARY GUID
K813624 · DQO
Advanced Catheter Systems
Cardiovascular · 24d
Cleared Jan 22, 1982
SERIES 400 DISPOSABLE TEMPERATURE PROBE
K813639 · FLL
Yellow Springs Instrument Co., Inc.
General Hospital · 22d
Cleared Jan 22, 1982
MICROMEDIC HTSH RIA KIT
K813645 · JLW
Micromedic Systems
Chemistry · 22d
Cleared Jan 22, 1982
TOTAL HEMOLYTIC COMPLEMENT TEST KIT
K820005
Meloy Laboratories, Inc.
Immunology · 18d
Cleared Jan 22, 1982
ZEON COMPOSITE RESIN SYSTEM
K820006 · EBF
National Patent Development Corp.
Dental · 18d
Cleared Jan 22, 1982
ARROW JUGULAR PUNCTURE KIT 16 GA.
K820009 · DQY
Arrow Intl., Inc.
Cardiovascular · 17d
Cleared Jan 22, 1982
CARDIOSTRESS
K820011 · DPS
Instruments For Cardiac Research
Cardiovascular · 17d
Cleared Jan 22, 1982
SPRYCE, DENTURE CLEANSER
K820020 · EFT
Richardson-Vicks, Inc.
Dental · 17d
Cleared Jan 22, 1982
CARDIOVUE ACCESSORY CART
K820033 · DSF
Diasonics, Inc.
Cardiovascular · 16d
Cleared Jan 22, 1982
CXD 400
K820036 · BZG
Cdx Corp.
Anesthesiology · 15d
Cleared Jan 22, 1982
LEECO PRL-QUANT DIAGNOSTIC TEST KIT
K820039 · CFT
Leeco Diagnostics, Inc.
Chemistry · 15d
Cleared Jan 22, 1982
BOSCH TOP STAR III
K820041 · ESD
Bosch Hearing Instruments, Inc.
Ear, Nose, Throat · 15d
Cleared Jan 19, 1982
MICRO MED INT'L MICRO SOUND US-100
K812752 · IMI
N-Tron Electronics
Physical Medicine · 112d
Cleared Jan 19, 1982
ABBOTT PAP-EIA
K812925 · JFH
Abbott Laboratories
Chemistry · 92d