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: Cleared only ×
174,955 results
106345–106368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1994
LMT ARTHROSCOPIC SUTURING INSTRUMENTS
K941964 · HRX
Li Medical Technologies, Inc.
Orthopedic · 159d
Cleared Sep 28, 1994
MANUAL SURGICAL INSTRUMENTS
K942079 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 152d
Cleared Sep 28, 1994
INFINITY REVISION HIP STEM
K942115 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 148d
Cleared Sep 28, 1994
GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER
K942574 · GCJ
Acufex Microsurgical, Inc.
General & Plastic Surgery · 120d
Cleared Sep 28, 1994
FOUNDATION ALL POLY CUP
K942611 · JDI
Encore Orthopedics, Inc.
Orthopedic · 118d
Cleared Sep 28, 1994
ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA
K942834 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 105d
Cleared Sep 28, 1994
ACUFEX(R) ENDO-FEMORAL AIMER
K942846 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 104d
Cleared Sep 28, 1994
SILHOUETTE, SUNLIMETED,ADIDAS
K944160 · HQZ
Silhouette Optical , Ltd.
Ophthalmic · 33d
Cleared Sep 28, 1994
SPECTACLE FRAMES
K944373 · HQZ
Custom Optical Frames, Inc.
Ophthalmic · 21d
Cleared Sep 28, 1994
CARRIER, LIGATURE (79 GEJ)
K944465 · GCJ
Endotec, Inc.
General & Plastic Surgery · 16d
Cleared Sep 27, 1994
MODEL 4800 ACCUPACE PACING SYSTEM ANALYER
K925143 · DTE
Pace Medical
Cardiovascular · 714d
Cleared Sep 27, 1994
SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE
K925333 · HGI
Aspen Labs
Obstetrics & Gynecology · 706d
Cleared Sep 27, 1994
TUBAL LUMEN SUPPORT
K932114 · HFJ
Cook Ob/Gyn
Obstetrics & Gynecology · 512d
Cleared Sep 27, 1994
CONSENSUS KNEE SYSTEM - PRIMARY KNEE
K932837 · JWH
U.S. Medical Products, Inc.
Orthopedic · 473d
Cleared Sep 27, 1994
LUNG DIFFUSION
K935309 · BZC
Acetylene Gas Co.
Anesthesiology · 329d
Cleared Sep 27, 1994
CONBIO CUB-D10 COOPER LASER SYSTEM
K942934 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 97d
Cleared Sep 27, 1994
IRRIGATION/BIPOLAR SET
K942944 · GEI
Surgin Surgical Instrumentation, Inc.
General & Plastic Surgery · 97d
Cleared Sep 27, 1994
SINGLE STICK RADIALLY EXPANDING DILATOR
K943056 · GCJ
Innerdyne Medical, Inc.
General & Plastic Surgery · 92d
Cleared Sep 27, 1994
BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTS
K943470 · MGQ
Levtrade Intl. (Pty) , Ltd.
General & Plastic Surgery · 70d
Cleared Sep 27, 1994
BURNFREE BURNSOOTHE HYDROGEL
K943728 · MGQ
Levtrade Intl. (Pty) , Ltd.
General & Plastic Surgery · 70d
Cleared Sep 27, 1994
PEDI-CAP
K944400 · CCK
Nellcor, Inc.
Anesthesiology · 19d
Cleared Sep 27, 1994
DEKALB
K944414 · GCJ
Endotec, Inc.
General & Plastic Surgery · 19d
Cleared Sep 26, 1994
ANTI-RETICULIN ANTIBODY (ARA) TEST
K913360 · DBL
Immco Diagnostics, Inc.
Immunology · 1155d
Cleared Sep 26, 1994
STERIKING, SEE & PEEL
K922440 · KCT
Cox Sterile Products, Inc.
General Hospital · 857d