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: Orthopedic ×
17,850 results
15385–15408 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 25, 1994
SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES
K934332 · HRX
Friatec Medical Inc., USA
Orthopedic · 199d
Cleared Mar 25, 1994
AUTO SUTURE DISPOSABLE ARTHROSCOPIC TROCAR AND SLEEVE
K934720 · HRX
United States Surgical, A Division of...
Orthopedic · 175d
Cleared Mar 25, 1994
GRASPING FORCEPS, PUNCHES, SCISSORS
K940454 · HRX
L.A.S.E.R., Inc.
Orthopedic · 52d
Cleared Mar 24, 1994
ARTHTOTEK PRECISION HAND INSTRUMENTATION
K933070 · HRX
Biomet, Inc.
Orthopedic · 275d
Cleared Mar 24, 1994
ACUMED CARPAL TUNNEL RELEASE KIT
K933638 · HRX
Acu Med, Inc.
Orthopedic · 240d
Cleared Mar 24, 1994
ARTHROTEK CANNULA SYSTEM
K934401 · HRX
Biomet, Inc.
Orthopedic · 196d
Cleared Mar 23, 1994
ACUFEX ADJUSTABLE-LENGTH CANNULA
K934181 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 209d
Cleared Mar 23, 1994
GORE SMOOTHER CRUCIAL TOOL
K936206 · HRX
W.L. Gore & Associates, Inc.
Orthopedic · 84d
Cleared Mar 23, 1994
ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE
K940480 · HTJ
Acufex Microsurgical, Inc.
Orthopedic · 49d
Cleared Mar 22, 1994
BONE CEMENT RESTRICTOR
K926216 · JDK
Biodynamic Technologies, Inc.
Orthopedic · 467d
Cleared Mar 22, 1994
ACUFEX MENISCAL RASPS
K932460 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 305d
Cleared Mar 22, 1994
ACE HUMERAL NAIL
K934643 · HSB
Ace Orthopedic Manufacturing Co.
Orthopedic · 174d
Cleared Mar 22, 1994
AIM SUPRACONDYLAR NAIL
K934962 · HSB
Ace Orthopedic Manufacturing Co.
Orthopedic · 155d
Cleared Mar 21, 1994
POROCOAT POROUS COATING
K931641 · LPH
Depuy, Inc.
Orthopedic · 353d
Cleared Mar 21, 1994
ACUFEX METAL ACL CANNULA
K932718 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 290d
Cleared Mar 18, 1994
DISPOSABLE ARTHROSCOPIC ACCESSORY
K933949 · HRX
United States Surgical, A Division of...
Orthopedic · 218d
Cleared Mar 17, 1994
HA TI-FIT ACETABULAR AND FEMORAL COMPONENT
K922621 · MEH
Smith & Nephew Richards, Inc.
Orthopedic · 652d
Cleared Mar 14, 1994
SYNTHES UNREAMED HUMERAL NAIL (URHN)
K933518 · HSB
Synthes (Usa)
Orthopedic · 237d
Cleared Mar 14, 1994
GAMMA LOCKING NAIL MODIFICATION
K940286 · KTT
Howmedica, Inc.
Orthopedic · 63d
Cleared Mar 11, 1994
ARTHREX TIBIAL TUNNEL CANNULA
K930152 · HRX
Arthrex, Inc.
Orthopedic · 423d
Cleared Mar 10, 1994
PELVIC C-CLAMP
K922796 · JEC
Synthes (Usa)
Orthopedic · 639d
Cleared Mar 10, 1994
ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)
K925345 · LZO
Biomet, Inc.
Orthopedic · 504d
Cleared Mar 10, 1994
SYNTHES STERILE PINLESS EXTERNAL FIXATOR
K925460 · KTT
Synthes (Usa)
Orthopedic · 497d
Cleared Mar 10, 1994
ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM
K926395 · LZO
Depuy, Inc.
Orthopedic · 444d