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
107089–107112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1994
APR II FEMORAL COMPONENT (VARIOUS)
K942330 · LZO
Intermedics Orthopedics
Orthopedic · 141d
Cleared Oct 04, 1994
HITACHI 914 ANALYZER
K942364 · JJE
Boehringer Mannheim Corp.
Chemistry · 140d
Cleared Oct 04, 1994
KOVA LIQUA-TROL
K942853 · JJW
Hycor Biomedical, Inc.
Chemistry · 110d
Cleared Oct 04, 1994
P.A.T. SYSTEM
K943035 · ILQ
Mathews Assoc., Inc.
Physical Medicine · 99d
Cleared Oct 04, 1994
OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM
K943054 · LPH
Osteonics Corp.
Orthopedic · 99d
Cleared Oct 04, 1994
MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM
K943345 · JEY
Patton, Boggs & Blow
Dental · 84d
Cleared Oct 04, 1994
MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM
K943346 · JEY
Patton, Boggs & Blow
Dental · 84d
Cleared Oct 04, 1994
KLS MINI OSTEOSYNTHESIS SYSTEM
K943347 · JEY
Patton, Boggs & Blow
Dental · 84d
Cleared Oct 04, 1994
KLS CHIN PLATE SYSTEM
K943348 · JEY
Patton, Boggs & Blow
Dental · 84d
Cleared Oct 04, 1994
PATIENT TROLLEY 545
K943528 · FPO
Merivaara Instrumentarium Corp.
General Hospital · 75d
Cleared Oct 04, 1994
PATIENT TROLLEY 540
K943529 · FPO
Merivaara Instrumentarium Corp.
General Hospital · 75d
Cleared Oct 04, 1994
HICHEM ENZYME VERIFIER KIT
K943684 · JJT
Hi Chem, Inc.
Chemistry · 67d
Cleared Oct 04, 1994
ACRYDERM ADVANCED WOUND DRESSING
K943781 · KMF
Acrymed, Inc.
General & Plastic Surgery · 62d
Cleared Oct 04, 1994
SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING
K943925 · JJR
Quantimetrix Corp.
Chemistry · 53d
Cleared Oct 04, 1994
KARL STORZ LARYNGOSCOPE ACCESSORIES
K944295 · CAI
KARL STORZ Endoscopy-America, Inc.
Anesthesiology · 36d
Cleared Oct 04, 1994
BRAIN HEART INFUSION AGAR
K944554 · JSO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 18d
Cleared Oct 04, 1994
HP M1722A/B AND M1723A/B CODEMASTER
K944608 · DQA
Hewlett-Packard Co.
Anesthesiology · 15d
Cleared Oct 04, 1994
AUTONEB ACCESSORY CROSS (AAC)
K944643 · CAF
Vortran Medical Technology 1, Inc.
Anesthesiology · 13d
Cleared Oct 04, 1994
LIFE PULSE TESUSCITATION TIMER
K944667 · PMK
Green Field Medical Sourcing, Inc.
Anesthesiology · 14d
Cleared Oct 03, 1994
FEMININE HEAT WRAP
K924970 · IRT
Conair Corp.
Physical Medicine · 733d
Cleared Oct 03, 1994
SWEMED NEEDLE GUIDE
K925999 · IYO
Swemed Lab Intl.
Radiology · 675d
Cleared Oct 03, 1994
E-Z THERM 3 SECOND THERMOMETER
K932204 · FLL
North American Technical Services Corp.
General Hospital · 515d
Cleared Oct 03, 1994
AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER
K933916 · IYN
Ausonics Pty , Ltd.
Radiology · 418d
Cleared Oct 03, 1994
THE CRADLE
K933964 · IKZ
The Primal Energy Research Foundation
Physical Medicine · 413d