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
97009–97032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1996
QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)
K962325 · EJT
Sterngold/Implamed
Dental · 37d
Cleared Jul 24, 1996
STERNGOLD BIO-5 (1127210)
K962326 · EJT
Sterngold/Implamed
Dental · 37d
Cleared Jul 23, 1996
CHEMCARD GLUCOSE TEST
K943503 · CGA
Chem-Elec, Inc.
Chemistry · 734d
Cleared Jul 23, 1996
CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)
K953875 · MQS
In-Line Diagnostics Corp.
Gastroenterology & Urology · 391d
Cleared Jul 23, 1996
STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY
K954326 · JIT
Solarcare Technologies Corp,Inc.
Chemistry · 312d
Cleared Jul 23, 1996
G3000 OR AG2000
K955815 · DRX
Cmc Sense-It, Inc.
Cardiovascular · 210d
Cleared Jul 23, 1996
DIAO HAND SURGERY SET
K960539 · HXB
Kinetikos Medical, Inc.
Orthopedic · 167d
Cleared Jul 23, 1996
SUBTALAR MBA SYSTEM
K960692 · HWC
Kinetikos Medical, Inc.
Orthopedic · 154d
Cleared Jul 23, 1996
PRISM 3000XPV SYSTEM (210714)
K961577 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 90d
Cleared Jul 23, 1996
URIC ACID-SL ASSAY CATALOGUE NO. 237-60
K961586 · KNK
Diagnostic Chemicals , Ltd.
Chemistry · 90d
Cleared Jul 23, 1996
MEGATRON OPHTHALMIC SURGICAL SYSTEM
K961658 · HQC
Intl. Ophthalmic Industries Corp.
Ophthalmic · 85d
Cleared Jul 23, 1996
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
K961824 · DCF
Roche Diagnostic Systems, Inc.
Immunology · 74d
Cleared Jul 23, 1996
QUICKSTICK ONE STEP PREGNANCY TEST(9010)
K962219 · LCX
Phamatech
Chemistry · 43d
Cleared Jul 23, 1996
STERNGOLD BIO-4
K962304 · EJS
Sterngold/Implamed
Dental · 36d
Cleared Jul 23, 1996
CTM REUSABLE PAK
K962430 · HQC
Circuit Tree Medical, Inc.
Ophthalmic · 29d
Cleared Jul 23, 1996
CTM DISPOSABLE PAK
K962431 · HQC
Circuit Tree Medical, Inc.
Ophthalmic · 29d
Cleared Jul 23, 1996
STA - VWF CONTROL [N]+[P] KIT
K962674 · GGN
American Bioproducts Co.
Hematology · 14d
Cleared Jul 22, 1996
LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS
K953813 · LTZ
London International U.S. Holdings, Inc.
Obstetrics & Gynecology · 353d
Cleared Jul 22, 1996
STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
K954156 · KQO
Solarcare Technologies Corp,Inc.
Chemistry · 321d
Cleared Jul 22, 1996
MB/BACT MYCROBACTERIA DETECTION SYSTEM
K954468 · MDB
Organon Teknika Corp.
Microbiology · 300d
Cleared Jul 22, 1996
URITEST - NITRITE IN URINE TEST
K954685 · JMT
Tcpi, Inc.
Chemistry · 285d
Cleared Jul 22, 1996
INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
K955360 · LFZ
Incstar Corp.
Microbiology · 243d
Cleared Jul 22, 1996
INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
K955361 · LFZ
Incstar Corp.
Microbiology · 243d
Cleared Jul 22, 1996
CVM TRANSPORT
K955451 · JSM
Hardy Diagnostics
Microbiology · 236d