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
143809–143832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1986
WECK-KREEM, CATALOG NO. 850-155
K861589
Palmetto Chemical & Supply Co., Inc.
General & Plastic Surgery · 24d
Cleared May 23, 1986
WECK-LUBE, CATALOG NO. 850-150
K861591
Palmetto Chemical & Supply Co., Inc.
General & Plastic Surgery · 24d
Cleared May 23, 1986
TOTAL IRON BINDING CAPACITY PROCEDURE
K861602 · CFM
Data Medical Associates, Inc.
Chemistry · 24d
Cleared May 23, 1986
IRON PROCEDURE
K861603 · JJY
Data Medical Associates, Inc.
Chemistry · 24d
Cleared May 23, 1986
SALICYLATE REAGENT SET
K861615 · DKJ
Sterling Diagnostics, Inc.
Toxicology · 24d
Cleared May 23, 1986
LIQUID CHROMATOGRAPHY COLUMNS
K861633 · DPM
Supelco, Inc.
Toxicology · 24d
Cleared May 23, 1986
MODUMATIC (R) DILUTER
K861640 · JQW
Tri-Continent Scientific, Inc.
Chemistry · 23d
Cleared May 23, 1986
GLUCOSE HK PROCEDURE
K861653 · CGA
Data Medical Associates, Inc.
Chemistry · 23d
Cleared May 23, 1986
SERUM POTASSIUM REAGENT SET
K861713 · CEJ
Sterling Diagnostics, Inc.
Chemistry · 18d
Cleared May 23, 1986
3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE
K861749 · FSP
Keeler Instruments, Inc.
General & Plastic Surgery · 17d
Cleared May 23, 1986
THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS
K861751 · KNN
Special Health Systems, Ltd.
Physical Medicine · 17d
Cleared May 23, 1986
KINESETHETIC SEATING SYSTEM/WHEELCHAIR
K861754 · KNN
Special Health Systems, Ltd.
Physical Medicine · 17d
Cleared May 23, 1986
SHS CUSHION/WHEELCHAIR
K861755 · KNN
Special Health Systems, Ltd.
Physical Medicine · 17d
Cleared May 23, 1986
MEDCARE SUTURE REMOVAL KIT
K861804
Medcomp Technologies, Inc.
General & Plastic Surgery · 14d
Cleared May 23, 1986
MEDCARE FORCEPS (THUMB, TISSUE)
K861805 · GEN
Medcomp Technologies, Inc.
General & Plastic Surgery · 14d
Cleared May 23, 1986
MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)
K861806 · KDA
Medcomp Technologies, Inc.
General & Plastic Surgery · 14d
Cleared May 23, 1986
MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)
K861807 · HRQ
Medcomp Technologies, Inc.
General & Plastic Surgery · 14d
Cleared May 21, 1986
MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS
K853912 · JAQ
Nucletron-Oldelft Corp.
Radiology · 243d
Cleared May 21, 1986
THE M100 AIR/OXYGEN MIXER
K860373 · BZR
Newport Medical Instruments, Inc.
Anesthesiology · 107d
Cleared May 21, 1986
PTR MK II VENTILATOR
K860692 · BYT
Bear Medical Systems, Inc.
Anesthesiology · 85d
Cleared May 21, 1986
CHECK-UP PLAQUE FIGHTING GUM
K860843 · EJR
Minnetonka, Inc.
Dental · 76d
Cleared May 21, 1986
STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL
K860920 · DTR
Shiley, Inc.
Cardiovascular · 71d
Cleared May 21, 1986
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
K860980 · DSI
Spacelabs, Inc.
Cardiovascular · 71d
Cleared May 21, 1986
RMI CAROTID BY-PASS SHUNT
K860988 · DWF
Research Medical, Inc.
Cardiovascular · 65d