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
137377–137400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 1987
RESUBMITTED STANDARD MICROPORE ECG ELECTRODE
K874628 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 46d
Cleared Dec 04, 1987
COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION
K872576 · GQH
Enzo Biochem, Inc.
Microbiology · 157d
Cleared Dec 04, 1987
DGH-3000A A-SCAN
K872726 · IYO
Dgh Technology, Inc.
Radiology · 149d
Cleared Dec 04, 1987
STRUNG DENTAL ROLLS
K872810 · EFN
American Silk Sutures, Inc.
Dental · 143d
Cleared Dec 04, 1987
LEWIS SAFE SLEEVE
K873960 · EIF
Cheri Lewis, D.D.S.
Dental · 67d
Cleared Dec 04, 1987
ENTERON ABDOMINAL PARACENTESIS TRAY
K874063 · KDD
Endovations
General & Plastic Surgery · 60d
Cleared Dec 04, 1987
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K874131 · CIC
Pointe Scientific, Inc.,
Chemistry · 52d
Cleared Dec 04, 1987
MODIFIED USE OF TRIANGLE BANDAGE STERILE
K874161 · NAD
K. W. Griffen Co.
General & Plastic Surgery · 52d
Cleared Dec 04, 1987
BIOTIS (TM) STARCH HYDROLYSIS WITH BCP
K874174 · JSF
Otisville Biopharm, Inc.
Microbiology · 52d
Cleared Dec 04, 1987
BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC
K874175 · JSF
Otisville Biopharm, Inc.
Microbiology · 52d
Cleared Dec 04, 1987
BIOTIS (TM) BCYE
K874177 · KZI
Otisville Biopharm, Inc.
Microbiology · 50d
Cleared Dec 04, 1987
BIOTIS (TM) BCYE SELECTIVE
K874178 · JSJ
Otisville Biopharm, Inc.
Microbiology · 52d
Cleared Dec 04, 1987
HEMO-SOL
K874461 · KEM
Chem Pharm, Inc.
Pathology · 36d
Cleared Dec 04, 1987
BERNAFON COLIBRI, C-2H HEARING AIDS
K874589 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 25d
Cleared Dec 04, 1987
REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100
K874639 · KXJ
Shimadzu Precision Instruments, Inc.
Radiology · 22d
Cleared Dec 03, 1987
MICRO-GUIDE
K870700 · DQO
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 287d
Cleared Dec 03, 1987
NUMED PTA CATHETERS
K871796 · LIT
NuMED, Inc.
Cardiovascular · 210d
Cleared Dec 03, 1987
MSS ENTERAL DELIVERY SET
K872921 · KNT
Medical Support, Inc.
Gastroenterology & Urology · 129d
Cleared Dec 03, 1987
TEMPORARY PACEMAKER ELECTRODE
K872972 · LDF
Oscor Medical Corp.
Cardiovascular · 127d
Cleared Dec 03, 1987
CHEMO-PORT NON-CORING NEEDLES
K873165 · FMI
Hdc Corp.
General Hospital · 114d
Cleared Dec 03, 1987
EDSLAB (R) OCCLUSION BALLOON CATHETER
K873485 · DQY
American Edwards Laboratories
Cardiovascular · 94d
Cleared Dec 03, 1987
STUBBIE STEERABLE GUIDEWIRE
K873543 · DQX
Target Therapeutics
Cardiovascular · 93d
Cleared Dec 03, 1987
MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR
K873672 · DRG
Novametrix Medical Systems, Inc.
Cardiovascular · 83d
Cleared Dec 03, 1987
STERILIZED DENTAL BIT PACKAGING
K873698 · EJL
Florida Diamond Instruments Corp.
Dental · 80d