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
129025–129048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1989
FPR PHENYTOIN KIT
K894527 · DLP
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Sep 25, 1989
FPR PHENYTOIN CALIBRATOR KIT
K894528 · DLG
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Sep 25, 1989
COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS
K895143 · GEX
Lumenis, Inc.
General & Plastic Surgery · 38d
Cleared Sep 25, 1989
LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II
K895210 · DKZ
Abbott Laboratories
Toxicology · 38d
Cleared Sep 25, 1989
ACTIDERM (TM) DERMATOLOGICAL PATCH
K895376 · KGX
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 26d
Cleared Sep 22, 1989
COIL AND COIL DELIVERY SYSTEM
K891688 · HCG
Target Therapeutics
Neurology · 184d
Cleared Sep 22, 1989
HOLTAIN BODY COMPOSITION ANALYSER
K891928 · DSB
Seritex, Inc.
Cardiovascular · 178d
Cleared Sep 22, 1989
PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE)
K892670 · BZC
Physio-Dyne Instrument Corp.
Anesthesiology · 162d
Cleared Sep 22, 1989
THE INDEPENDENT CARE UNIT
K893745 · FNL
The Water Carriage Co., Inc.
General Hospital · 127d
Cleared Sep 22, 1989
SERVO ANESTHESIA CIRCLE 985
K893786 · CBK
Siemens Life Support Systems
Anesthesiology · 123d
Cleared Sep 22, 1989
PREMISE SERIES BED
K894296 · FNL
Batesville American Mfg. Co.
General Hospital · 92d
Cleared Sep 22, 1989
REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM
K894299 · BSY
Repro-Med Systems, Inc.
Anesthesiology · 92d
Cleared Sep 22, 1989
AMADEUS VENTILATOR
K894316 · CBK
Hamilton Medical, Inc.
Anesthesiology · 70d
Cleared Sep 22, 1989
HTF WITH ALBUMIN (CATALOG NO. 9994)
K894405 · HDR
Irvine Scientific
Obstetrics & Gynecology · 67d
Cleared Sep 22, 1989
X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS
K894413 · ITY
Inmark Corp.
Radiology · 67d
Cleared Sep 22, 1989
MODIFIED HAM'S F-10 W/ALBUMIN
K894432 · HDR
Irvine Scientific
Obstetrics & Gynecology · 67d
Cleared Sep 22, 1989
NATIONAL MEDICAL CARE VENOUS LINE 03-9548
K894637 · KOC
National Medical Care, Medical...
Gastroenterology & Urology · 60d
Cleared Sep 22, 1989
16 GA X 6 BULLET POINT NEEDLE
K894872 · GAA
R. J. Doyle, Inc.
General & Plastic Surgery · 52d
Cleared Sep 22, 1989
16 GA X 10 BULLET POINT NEEDLE
K894873 · GAA
R. J. Doyle, Inc.
General & Plastic Surgery · 52d
Cleared Sep 22, 1989
14 INCH BULLET POINT NEEDLE
K894874 · GAA
R. J. Doyle, Inc.
General & Plastic Surgery · 52d
Cleared Sep 22, 1989
20GA X 7-1/2 THREADING BULLET POINT NEEDLE
K894875 · GAA
R. J. Doyle, Inc.
General & Plastic Surgery · 52d
Cleared Sep 22, 1989
SHIMADZU X-RAY TUBE STAND FH-31
K895188 · IYB
Shimadzu Medical Systems
Radiology · 42d
Cleared Sep 22, 1989
MODIFIED MEMORY RETRACTOR ARM
K895537 · GZT
Medical Equipment Development Co., Inc.
Neurology · 10d
Cleared Sep 22, 1989
VVR/Q CALORIMETER
K895586 · BZL
Vita-Stat
Anesthesiology · 7d