FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
110377–110400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 1994
DEROYAL SURGICAL DISPOSABLE INSUFFLATION TUBING
K934131 · HIF
Deroyal Industries, Inc.
Obstetrics & Gynecology · 194d
Cleared Mar 07, 1994
OPUS(R) SEROLOGY CONTROLS, MODIFICATION
K934137 · MJX
Pb Diagnostic Systems, Inc.
Microbiology · 194d
Cleared Mar 07, 1994
BIP BIOPSY NEEDLE MODIFICATION
K934370 · FCG
Bip USA, Inc.
Gastroenterology & Urology · 181d
Cleared Mar 07, 1994
MAST CLA ALLERGY SYSTEM
K934524 · DHB
Mast Immunosystems
Immunology · 168d
Cleared Mar 07, 1994
EXTRA CARE
K934721 · LYY
Genting Sempurna Sdn. Bhd.
General Hospital · 158d
Cleared Mar 07, 1994
CONMED UNIVERSAL PLUS
K934828 · GEI
Conmedcorp
General & Plastic Surgery · 150d
Cleared Mar 07, 1994
3D VIDEO SYSTEM
K934883 · FWG
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 146d
Cleared Mar 07, 1994
MIRACLE-EAR ENTRE
K934940 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 140d
Cleared Mar 07, 1994
ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR
K934964 · FLL
Electromedics, Inc.
General Hospital · 143d
Cleared Mar 07, 1994
BIOMETRIC TOTAL HIP SYSTEM
K935012 · JDI
Osteo-Technology Intl., Inc.
Orthopedic · 138d
Cleared Mar 07, 1994
FACTOR X DEFICIENT PLASMA
K935054 · GJT
Sigma Diagnostics, Inc.
Hematology · 137d
Cleared Mar 07, 1994
FACTOR VII DEFICIENT PLASMA
K935056 · GJT
Sigma Diagnostics, Inc.
Hematology · 137d
Cleared Mar 07, 1994
FACTOR
K935058 · GJT
Sigma Diagnostics, Inc.
Hematology · 137d
Cleared Mar 07, 1994
MAXXUS ORTHOPAEDIC LATEX SURGICAL GLOVES
K935227 · KGO
Johnson & Johnson Medical, Inc.
General Hospital · 126d
Cleared Mar 07, 1994
PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS
K935276 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 124d
Cleared Mar 07, 1994
CONMED VENI-GARD I.V. DRESSING
K935389 · KMK
Conmedcorp
General Hospital · 119d
Cleared Mar 07, 1994
SNJ SMOKE EVACUATION SUCTION WAND
K935439 · FYD
Lca, Inc.
General Hospital · 115d
Cleared Mar 07, 1994
DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET
K935503 · HIF
Davol, Inc.
Obstetrics & Gynecology · 111d
Cleared Mar 07, 1994
URINARY DRAINAGE BAG
K935557 · KNX
Puritas Health Care, Inc.
Gastroenterology & Urology · 110d
Cleared Mar 07, 1994
INSTANT HOT OR COLD DISPOSABLE PACK
K935569 · IMD
Cryopak Industries, Inc.
Physical Medicine · 109d
Cleared Mar 07, 1994
SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT
K935572 · FTC
Solarc Systems, Inc.
General & Plastic Surgery · 109d
Cleared Mar 07, 1994
FLOWGUN REUSABLE IRRIGATION PROBES
K935645 · GCJ
O.R. Concepts, Inc.
General & Plastic Surgery · 104d
Cleared Mar 07, 1994
MEDICOTEX(TRADEMARK APPLICATION PENDING)
K935660 · FYA
Itochu International, Inc.
General Hospital · 101d
Cleared Mar 07, 1994
SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE
K935694 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 98d