Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Orthopedic ×
17,985 results
16009–16032 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 19, 1992
MODEL AR-6300 INFUSION PUMP
K915721 · HRX
Arthrex, Inc.
Orthopedic · 90d
Cleared Mar 19, 1992
S-ROM LF FEMORAL HEAD
K920317 · JDI
Joint Medical Products Corp.
Orthopedic · 55d
Cleared Mar 18, 1992
DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC
K920034 · JWH
Pfizer Hospital Products Group, Inc.
Orthopedic · 72d
Cleared Mar 16, 1992
BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN
K915800 · JEC
Bremer Medical, Inc.
Orthopedic · 83d
Cleared Mar 13, 1992
DRG CEMETED STEM
K920003 · JDI
Intermedics Orthopedics
Orthopedic · 71d
Cleared Mar 12, 1992
AESCULAP TITANIUM BONE PLATES
K913730 · KWQ
Aesculap, Inc.
Orthopedic · 205d
Cleared Mar 11, 1992
BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD
K915596 · KWT
Biomet, Inc.
Orthopedic · 89d
Cleared Mar 10, 1992
IONGUARD TITANIUM MODULAR HEADS
K915548 · LZY
Biomet, Inc.
Orthopedic · 90d
Cleared Mar 06, 1992
SUCTION CONTROL FOOTSWITCH WITH SPEED CONTROL
K913401 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 220d
Cleared Mar 04, 1992
PERFECTA PDA TOTAL HIP SYSTEM
K915795 · JDI
Orthomet, Inc.
Orthopedic · 65d
Cleared Mar 02, 1992
INTERLOCKING TIBIAL NAILING SYSTEM
K915435 · HSB
Stryker Corp.
Orthopedic · 90d
Cleared Feb 28, 1992
CORTICAL BONE SCREW
K915448 · HWC
Dow Corning Wright
Orthopedic · 81d
Cleared Feb 20, 1992
AAP BONE PLATE
K915315 · HRS
Aap International, Ltd.
Orthopedic · 90d
Cleared Feb 19, 1992
KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
K915309 · LZO
Kinamed, Inc.
Orthopedic · 89d
Cleared Feb 19, 1992
KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
K915310 · LZO
Kinamed, Inc.
Orthopedic · 89d
Cleared Feb 18, 1992
CONTINUUM KNEE SYSTEM (CKS)
K914072 · JWH
Techmedica, Inc.
Orthopedic · 160d
Cleared Feb 18, 1992
UNIVERSAL FEMORAL NAIL
K914371 · JDS
Synthes (Usa)
Orthopedic · 140d
Cleared Feb 18, 1992
UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL
K914453 · JDS
Synthes (Usa)
Orthopedic · 137d
Cleared Feb 18, 1992
SMALL JOINT SYSTEM
K914559 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 126d
Cleared Feb 14, 1992
DANEK SPINALSCOPE
K901692 · HRX
Danek Medical, Inc.
Orthopedic · 674d
Cleared Feb 14, 1992
7000 SERIES TOTAL KNEE PATELLAR COMPONENTS
K915186 · JWH
Osteonics Corp.
Orthopedic · 88d
Cleared Feb 14, 1992
7000 SERIES MODULAR TIBIAL COMPONENTS
K915192 · JWH
Osteonics Corp.
Orthopedic · 87d
Cleared Feb 14, 1992
AAP BONE SCREW
K915316 · HWC
Aap International, Ltd.
Orthopedic · 84d
Cleared Feb 13, 1992
BONE SCREW 3.5 MM
K915613 · HWC
Acu Med, Inc.
Orthopedic · 59d