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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
119209–119232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1991
MONOCLONAL ANTIBODY ANTI-CD2
K901187 · GKZ
Sigma Chemical Co.
Hematology · 597d
Cleared Oct 31, 1991
MONOCLONAL ANTIBODY ANTI-CD5
K901188 · GKZ
Sigma Chemical Co.
Hematology · 597d
Cleared Oct 31, 1991
MONOCLONAL ANTIBODY ANTI-CD3
K901189 · GKZ
Sigma Chemical Co.
Hematology · 597d
Cleared Oct 31, 1991
CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC
K910473 · GKZ
Coulter Immunology
Hematology · 269d
Cleared Oct 31, 1991
CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY
K910530 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 265d
Cleared Oct 31, 1991
THROMBONOSTIKA F1.2
K911434 · MIF
Organon Teknika Corp.
Hematology · 212d
Cleared Oct 31, 1991
SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION
K911761 · DQA
S & W Medico Teknik
Anesthesiology · 223d
Cleared Oct 31, 1991
ACUSON V510 TRANSDUCER
K911767 · ITX
Acuson Corp.
Radiology · 195d
Cleared Oct 31, 1991
TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST
K912045 · DXS
Lifestream Int'L, Inc.
Cardiovascular · 176d
Cleared Oct 31, 1991
ACLAIMS-IS
K912085 · LNJ
W-Technology
Pathology · 171d
Cleared Oct 31, 1991
BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT
K912748 · LCP
Binax, Inc.
Hematology · 132d
Cleared Oct 31, 1991
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
K912807 · JFY
Em Diagnostic Systems, Inc.
Chemistry · 128d
Cleared Oct 31, 1991
OIA STREP A
K912889 · GTZ
Biosearch Medical Products, Inc.
Microbiology · 122d
Cleared Oct 31, 1991
DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH
K913235 · FMF
Davol, Inc.
General Hospital · 101d
Cleared Oct 31, 1991
MEGA ARTHROGRAM KIT
K913317 · FMI
Mega Medical, Inc.
General Hospital · 98d
Cleared Oct 31, 1991
MEGA ANGIOGRAM KIT
K913397 · DQO
Mega Medical, Inc.
Cardiovascular · 93d
Cleared Oct 31, 1991
HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS
K913451 · DSI
Hewlett-Packard Co.
Cardiovascular · 90d
Cleared Oct 31, 1991
SODIUM REAGENT SET
K914039 · CEI
Sterling Diagnostics, Inc.
Chemistry · 51d
Cleared Oct 31, 1991
QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE
K914672 · DRX
Medicotest, Inc.
Cardiovascular · 13d
Cleared Oct 30, 1991
EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
K911315 · KOC
Baxter Healthcare Corp
Gastroenterology & Urology · 218d
Cleared Oct 30, 1991
SMT-100X
K911975 · LNH
Shimadzu Medical Systems
Radiology · 180d
Cleared Oct 30, 1991
CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED
K912030 · CBZ
3M Company
Anesthesiology · 176d
Cleared Oct 30, 1991
MICRONAIRE ISO-HOOD MAX 5UV
K912142 · EAZ
Micronaire Corp.
Dental · 169d
Cleared Oct 30, 1991
URS-HYDRO-DILATOR MODEL NUMBER 2164.00
K912331 · EZN
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 159d