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
116857–116880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 1992
CD8 MONOCLONAL ANTIBODIES
K914847 · LIZ
Gen Trak, Inc.
Hematology · 235d
Cleared Jun 19, 1992
CD4 MONOCLONAL ANTIBODIES
K914848 · GKZ
Gen Trak, Inc.
Hematology · 235d
Cleared Jun 19, 1992
AMERICA SYSTEM
K920608 · KTT
I. Klimov Co.
Orthopedic · 129d
Cleared Jun 19, 1992
GREAT TOE IMPLANT
K920667 · LZJ
Acu Med, Inc.
Orthopedic · 127d
Cleared Jun 19, 1992
URINE CULTUR STABILIZATION TRANSPORT TUBE
K920761 · LIO
Bio Medicus, Inc.
Microbiology · 121d
Cleared Jun 19, 1992
COBAS CORE FERRITIN EIA
K920829 · JMG
Roche Diagnostic Systems, Inc.
Immunology · 116d
Cleared Jun 19, 1992
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024
K920927 · JJY
Helena Laboratories
Chemistry · 112d
Cleared Jun 19, 1992
BACTIDROP INDOLE (ERLICH'S)
K920973 · JTO
Remel Co.
Microbiology · 109d
Cleared Jun 19, 1992
BACTIDROP ACRIDINE ORANGE
K920974 · JFO
Remel Co.
Microbiology · 109d
Cleared Jun 19, 1992
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT
K921183 · DBM
Shield Diagnostics, Ltd.
Immunology · 102d
Cleared Jun 19, 1992
ULTRA-CORE BIOPSY NEEDLES
K921418 · DWO
Medical Device Technologies, Inc.
General & Plastic Surgery · 87d
Cleared Jun 19, 1992
DRYSLIDE(TM), PYR
K921583 · JTO
Difco Laboratories, Inc.
Microbiology · 102d
Cleared Jun 19, 1992
PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION
K922010 · MHI
Alexon, Inc.
Microbiology · 50d
Cleared Jun 19, 1992
AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS
K922160 · ILJ
Aquamotion, Inc.
Physical Medicine · 43d
Cleared Jun 19, 1992
KERATOREF L60
K922253 · HLQ
Luneau Ophtalmologie SA
Ophthalmic · 49d
Cleared Jun 19, 1992
ROADRUNNER ELECTRIC SCOOTER-3 WHEELED
K922304 · INI
Mobility Mfg. Co.
Physical Medicine · 35d
Cleared Jun 19, 1992
COYOTE ELECTRIC SCOOTER-3WHEELED
K922305 · INI
Mobility Mfg. Co.
Physical Medicine · 35d
Cleared Jun 19, 1992
CABLE COLUMN WEIGHT SYSTEM MODEL #940-200
K922602 · ISD
Biodan Medical Systems, Ltd.
Physical Medicine · 17d
Cleared Jun 19, 1992
TOTAL WORK INTEGRATOR, MODEL #940-110
K922603 · ISD
Biodan Medical Systems, Ltd.
Physical Medicine · 17d
Cleared Jun 19, 1992
MULTI JOINT WEIGHT SYSTEM MODEL #940-100
K922606 · ISD
Biodan Medical Systems, Ltd.
Physical Medicine · 17d
Cleared Jun 19, 1992
SPUR ADULT WITH OPEN RESERVOIR SYSTEM
K922707 · BTM
Ambu, Inc.
Anesthesiology · 14d
Cleared Jun 19, 1992
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM
K922712 · BTM
Ambu, Inc.
Anesthesiology · 14d
Cleared Jun 18, 1992
ARROW QUADPOLAR MAPPING/PACING CATHETER
K911065 · DRF
Arrow Intl., Inc.
Cardiovascular · 463d
Cleared Jun 18, 1992
ACUSON C366 TRANSDUCER
K911916 · ITX
Acuson Corp.
Radiology · 415d