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
15625–15648 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 01, 1994
AME(R) RIGID FIXATION SYSTEM
K930531 · KWP
American Medical Electronics, Inc.
Orthopedic · 364d
Cleared Feb 01, 1994
PUNCH SURGICAL
K933772 · LXH
Mahe-Medizintechnik
Orthopedic · 187d
Cleared Jan 31, 1994
ARTHREX INSTRUMENTS ( HIP )
K926212 · HRX
Arthrex, Inc.
Orthopedic · 417d
Cleared Jan 28, 1994
SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM
K931395 · KIJ
Micro Surgical Instruments Corp.
Orthopedic · 315d
Cleared Jan 28, 1994
SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
K932653 · LGH
Carapace, Inc.
Orthopedic · 240d
Cleared Jan 28, 1994
SOFAMOR ORTHOPAEDIC INSTRUMENTS
K933242 · LXH
Danek Medical, Inc.
Orthopedic · 210d
Cleared Jan 28, 1994
SNAP BONE REAMER
K935322 · HWE
Surgiquip, Inc.
Orthopedic · 85d
Cleared Jan 27, 1994
UNIVERSAL BONE CEMENT KIT
K931540 · LZN
Biodynamic Technologies, Inc.
Orthopedic · 304d
Cleared Jan 27, 1994
PNEUMATIC WIRE TENSIONER
K934431 · HSZ
Smith & Nephew Richards, Inc.
Orthopedic · 136d
Cleared Jan 27, 1994
SNAP DRILL
K935516 · HWE
Surgiquip, Inc.
Orthopedic · 70d
Cleared Jan 26, 1994
ARTHREX INSTRUMENTS (WRIST)
K926303 · HRX
Arthrex, Inc.
Orthopedic · 407d
Cleared Jan 26, 1994
BONE SAW BLADES
K931176 · HWE
Betzler Mfg., Inc.
Orthopedic · 323d
Cleared Jan 26, 1994
INTERMEDICS ORTHOPEDICS REAMERS
K931733 · HTP
Intermedics Orthopedics
Orthopedic · 294d
Cleared Jan 26, 1994
ACUFLEX DISPOSABLE KNIVES
K933921 · HTS
Acufex Microsurgical, Inc.
Orthopedic · 169d
Cleared Jan 26, 1994
BARRIER BONE WAX APPLICATOR
K934260 · LXH
Phillips Pharmaceuticals, Inc.
Orthopedic · 148d
Cleared Jan 26, 1994
SPONGER CABLE SYSTEM, MODIFICATION
K935481 · JDQ
Pioneer Surgical Technology
Orthopedic · 125d
Cleared Jan 26, 1994
SURGICAL ACCESSORIES COCR CABLE SYSTEM
K935592 · JDQ
Surgical Accessories, Inc.
Orthopedic · 68d
Cleared Jan 25, 1994
P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT
K924340 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 515d
Cleared Jan 25, 1994
TRICK MODULAR KNEE TIBIAL TRAY-POROUS
K931054 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 330d
Cleared Jan 25, 1994
ARTHREX AR-8200 SHAVER SYSTEM
K932699 · HWE
Arthrex, Inc.
Orthopedic · 236d
Cleared Jan 25, 1994
MODIFICATION OF ANTERIOR SEGMENT ELECTRODES
K933527 · HWA
Mira, Inc.
Orthopedic · 189d
Cleared Jan 21, 1994
AMK LANDMARK REVISION KNEE SYSTEM
K925072 · JWH
Depuy, Inc.
Orthopedic · 471d
Cleared Jan 21, 1994
ACRYL-X II SYSTEM
K930629 · LZV
Sonokinetics, Inc.
Orthopedic · 347d
Cleared Jan 21, 1994
ACUFEX PRO-PAC AND ISO-PAC
K931621 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 294d