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
156841–156864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1983
AIR BURBINE HANDPIECE-DENTAL SCALING
K831037 · ELB
Taco Dental, Inc.
Dental · 39d
Cleared May 09, 1983
PHASE II T3 RADIOIMMUNOASSAY KIT
K831064 · CDP
Medical & Scientific Designs, Inc.
Chemistry · 35d
Cleared May 09, 1983
CONTAINER SYSTEM
K831068
Adler Instrument Co.
General & Plastic Surgery · 35d
Cleared May 09, 1983
CONNECTING TUBING
K831082 · BYX
The Kendall Company Div. of Tyco...
Anesthesiology · 35d
Cleared May 09, 1983
TENZCARE MUSCLE STIMULATION ELECTRODES
K831104 · GXY
3M Company
Neurology · 34d
Cleared May 09, 1983
LUO CURRETTES #3211
K831119 · FZS
Pmt, Inc.
General & Plastic Surgery · 34d
Cleared May 09, 1983
BIOCULT - GC CULTURE-PADDLES
K831124 · JTY
Orion Diagnostica, Inc.
Microbiology · 34d
Cleared May 09, 1983
CEFAXOLIN 30 MCG SENSI-DISC
K831153 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 31d
Cleared May 09, 1983
BLOOD CARDIOPLEGIA STAINLESS STEEL COOL
K831157 · DTR
American Bentley
Cardiovascular · 31d
Cleared May 09, 1983
LEAD ADAPTERS #'S 6016,6022,6017 ETC
K831160 · DTD
Cardiac Pacemakers, Inc.
Cardiovascular · 28d
Cleared May 09, 1983
ENERGETIC HI-HUM AERSOL UNIT
K831162 · CAF
Energetic Pulmonary
Anesthesiology · 28d
Cleared May 09, 1983
ENTERAL PUMP SET
K831167 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 28d
Cleared May 09, 1983
ENTERAL DELIVERY SET
K831168 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 28d
Cleared May 09, 1983
CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP
K831179 · JTN
General Diagnostics
Microbiology · 28d
Cleared May 09, 1983
CARDIO DATA PACEMAKER RECORDER
K831184 · DSH
Cardio Data
Cardiovascular · 28d
Cleared May 09, 1983
RAPID NFT
K831186 · JSN
Dms Laboratories
Microbiology · 27d
Cleared May 09, 1983
TRP
K831187 · JTO
Dms Laboratories
Microbiology · 27d
Cleared May 09, 1983
CONNECTOR TUBE
K831188 · DOY
Medrad, Inc.
Toxicology · 27d
Cleared May 09, 1983
ANGIOGRAPHIC NEEDLE
K831189 · DQO
Medrad, Inc.
Cardiovascular · 27d
Cleared May 09, 1983
VESSEL DILATOR
K831190 · DRE
Medrad, Inc.
Cardiovascular · 27d
Cleared May 09, 1983
VASCULAR CATHETER
K831191 · DOY
Medrad, Inc.
Toxicology · 27d
Cleared May 09, 1983
WESTERGREN DISPETTE FOR ESR
K831195 · JPH
Ulster Scientific, Inc.
Hematology · 27d
Cleared May 09, 1983
MODEL 343D HEARING AID
K831197 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 27d
Cleared May 09, 1983
IMMUNOHEMATOLOGICAL SALINE #97139
K831200 · JCE
Emd Chemicals, Inc.
Chemistry · 28d