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
98065–98088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1996
GLY-ETCH
K961190 · EBC
Centrix, Inc.
Dental · 28d
Cleared Apr 23, 1996
OPUS T3 CONTROLS
K961206 · JJX
Behring Diagnostics, Inc.
Chemistry · 27d
Cleared Apr 22, 1996
DIATHERMY DEVICE-MICROFOCUS
K941567 · IOA
Cheung Laboratories, Inc.
Physical Medicine · 752d
Cleared Apr 22, 1996
VIASPAN (BELZER UW - CSS)
K944866 · KDL
The Dupont Merck Pharmaceutical Co.
Gastroenterology & Urology · 567d
Cleared Apr 22, 1996
SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
K952879 · KFM
Baxter Healthcare Corp
Cardiovascular · 304d
Cleared Apr 22, 1996
PACETRAK PLUS
K954495 · DXH
Universal Medical, Inc.
Cardiovascular · 208d
Cleared Apr 22, 1996
PID-1 PRECISION INTELLIGENT DOSIMETER
K954564 · IYE
Gammex, Inc.
Radiology · 203d
Cleared Apr 22, 1996
5 FR PICC-LINE CATHETER
K954638 · LJS
Vygon Corp.
General Hospital · 199d
Cleared Apr 22, 1996
STOPCOCK & LUER LOCK PLUG
K954970 · FMG
Medex, Inc.
General Hospital · 175d
Cleared Apr 22, 1996
SURGICAL MASK (NON-STERILE)
K955513 · FXX
United Medical Ent., Inc.
General Hospital · 140d
Cleared Apr 22, 1996
KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE
K960323 · FGB
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 22, 1996
OSTEOGRAF/N-300 HYDROXYLAPATITE
K960348 · LYC
Ceramed Corp.
Dental · 88d
Cleared Apr 22, 1996
THERAVIEW
K960510 · IYE
Infimed, Inc.
Radiology · 77d
Cleared Apr 22, 1996
PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
K960993 · CAK
Pall Biomedical Products Co.
General Hospital · 41d
Cleared Apr 19, 1996
SARNS 800 ROLLER PUMP
K953901 · DWB
3M Health Care, Sarns
Cardiovascular · 245d
Cleared Apr 19, 1996
SARNS 9000 UNIVERSAL ROLLER PUMP
K953904 · DWB
3M Health Care, Ltd.
Cardiovascular · 245d
Cleared Apr 19, 1996
PATHROMTIN SL
K955450 · GFO
Behring Diagnostics, Inc.
Hematology · 142d
Cleared Apr 19, 1996
RELSIA SCL-70 ANTIBODY TEST SYSTEM
K955602 · LLL
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM
K955603 · LLL
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
RELISA SM/RNP ANTIBODY TEST SYSTEM
K955604 · LLL
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
RELISA JO-1 ANTIBODY TEST SYSTEM
K955605 · LLL
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
G.E. STERILE ANGIOGRAPHIC TRAY
K960139 · DWS
GE Medical Systems
Cardiovascular · 94d
Cleared Apr 19, 1996
RUSCH OPTOSAFE
K960240 · CAE
Rusch Intl.
Anesthesiology · 94d
Cleared Apr 19, 1996
PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK
K960294 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 88d