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
106105–106128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 1994
PROXIMAL HUMERAL REPLACEMENT SYSTEM
K925613 · KWT
Biomet, Inc.
Orthopedic · 708d
Cleared Oct 14, 1994
ORTHOMET ACETABULAR CUP SYSTEM
K931333 · LPH
Orthomet, Inc.
Orthopedic · 577d
Cleared Oct 14, 1994
ORTHOMET LHMC FEMORAL STEM
K931678 · HMC
Orthomet, Inc.
Ophthalmic · 556d
Cleared Oct 14, 1994
AXIOM TOTAL KNEE SYSTEM
K932677 · JWH
Orthomet, Inc.
Orthopedic · 499d
Cleared Oct 14, 1994
SOLUTION BOWED FEMORAL HIP PROTSTHESIS
K933942 · LZO
Depuy, Inc.
Orthopedic · 428d
Cleared Oct 14, 1994
LORAD TRANSPO
K934868 · IZH
Lorad Corp.
Radiology · 367d
Cleared Oct 14, 1994
CUFF-CATH
K935090 · FOZ
Ohmeda Medical
General Hospital · 357d
Cleared Oct 14, 1994
ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM
K935593 · HSD
Biodynamic Technologies, Inc.
Orthopedic · 329d
Cleared Oct 14, 1994
BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER
K936232 · DSP
Boston Scientific Corp
Cardiovascular · 289d
Cleared Oct 14, 1994
MICRO THERAPEUTICS INFUSION CATHETER
K940634 · FOZ
Micro Therapeutics, Inc.
General Hospital · 242d
Cleared Oct 14, 1994
RESCUE BREATHER
K940927 · CBP
O-Two Systems Intl., Inc.
Anesthesiology · 228d
Cleared Oct 14, 1994
ARTERIAL EMBOLIZATION DEVICE (KRD)
K940982 · KRD
Cook, Inc.
Cardiovascular · 227d
Cleared Oct 14, 1994
PRESERVATION UNICOMPARTMENTAL KNEE
K941606 · HSX
Depuy, Inc.
Orthopedic · 196d
Cleared Oct 14, 1994
AML TRILOCK REPLACEMENT LINER SYSTEM
K942966 · JDI
Depuy, Inc.
Orthopedic · 116d
Cleared Oct 14, 1994
MRT-150A
K943021 · LNH
Toshiba America Mri, Inc.
Radiology · 112d
Cleared Oct 14, 1994
AML TRI-LOCK REPLACEMENT LINER SYSTEM
K943302 · JDI
Depuy, Inc.
Orthopedic · 98d
Cleared Oct 14, 1994
CANNULATED BONE SCREW
K943474 · HWC
Cohort Medical Products Group, Inc.
Orthopedic · 87d
Cleared Oct 14, 1994
B-D GUARDIAN NESTABLE SHARPS COLLECTORS
K943575 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 84d
Cleared Oct 14, 1994
CHIN UP
K943837 · CCX
Edward Carden
Anesthesiology · 70d
Cleared Oct 14, 1994
RIGID TELESCOPES
K943904 · ENZ
Karl Storz Endoskop GmbH
Ear, Nose, Throat · 64d
Cleared Oct 14, 1994
HEAT AND MOISTURE EXCHANGER FILTER (HME)
K943915 · BYD
Medicomp, Inc.
Anesthesiology · 64d
Cleared Oct 14, 1994
ADAM SHELL THERMOCOUPLE ASSEMBLY
K944175 · BZG
Pro-Tech Services, Inc.
Anesthesiology · 49d
Cleared Oct 14, 1994
KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR
K944296 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 42d
Cleared Oct 14, 1994
CARBON LIGHTS HAND SURGERY TABLE
K944779 · FWZ
Allen Medical Systems, Inc.
General & Plastic Surgery · 17d