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
109777–109800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1994
HG MULTILOCK HIP PROSTHESIS W/ TI-NIDIUM
K921308 · LPH
Zimmer, Inc.
Orthopedic · 705d
Cleared Feb 22, 1994
BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT
K921557 · LPH
Zimmer, Inc.
Orthopedic · 692d
Cleared Feb 22, 1994
ZIMMER ANATOMIC HIP SYSTEM
K922071 · LPH
Zimmer, Inc.
Orthopedic · 659d
Cleared Feb 22, 1994
CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE
K923628 · HGI
Bruce Mclucas
Obstetrics & Gynecology · 581d
Cleared Feb 22, 1994
REFLEX(R) ESC
K924200 · KNF
Richard-Allan Medical Ind., Inc.
Obstetrics & Gynecology · 551d
Cleared Feb 22, 1994
PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
K924401 · GGC
Behring Diagnostics, Inc.
Hematology · 540d
Cleared Feb 22, 1994
CONTROL PLASMA U
K924402 · GGC
Behring Diagnostics, Inc.
Hematology · 540d
Cleared Feb 22, 1994
CONTROL PLASMA N
K924403 · GIZ
Behring Diagnostics, Inc.
Hematology · 540d
Cleared Feb 22, 1994
HOWMEDICAL TOTAL KNEE STEM EXTENDER
K924482 · JWH
Howmedica Corp.
Orthopedic · 537d
Cleared Feb 22, 1994
PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE)
K925172 · LPH
Howmedica Corp.
Orthopedic · 496d
Cleared Feb 22, 1994
BAXTER APD 12' EXTENSION LINE
K925403 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 487d
Cleared Feb 22, 1994
SOLARSHIELD CLIPS
K925531 · HQY
Dioptics Medical Products, Inc.
Ophthalmic · 477d
Cleared Feb 22, 1994
DURACON CRUCIFORM TIBIAL BASEPLATE
K926228 · JWH
Howmedica Corp.
Orthopedic · 438d
Cleared Feb 22, 1994
APC FEMORAL COMPONENT
K926229 · JDI
Howmedica Corp.
Orthopedic · 438d
Cleared Feb 22, 1994
FLOWGEL(R) TOPICAL WOUND DRESSING
K926353 · MGQ
Mediventures, Inc.
General & Plastic Surgery · 428d
Cleared Feb 22, 1994
AME UNIVERSAL BONE SCREW
K930107 · HWC
American Medical Electronics, Inc.
Orthopedic · 407d
Cleared Feb 22, 1994
THE SCITECH ONE-DAY FILTER
K930144 · EIA
Scitech Solutions, Inc.
Dental · 406d
Cleared Feb 22, 1994
MEGA PLUS SUPER LAG SCREW
K930156 · KTT
Pfizer Hospital Products Group, Inc.
Orthopedic · 405d
Cleared Feb 22, 1994
HOWMEDICA ACETABULAR SHELL
K930223 · JDI
Howmedica Corp.
Orthopedic · 403d
Cleared Feb 22, 1994
HOWMEDICA REVISION HIP SYSTEM
K930460 · JDI
Howmedica Corp.
Orthopedic · 390d
Cleared Feb 22, 1994
CUSTOM ORTHOPAEDIC TRAYS (PACKS)
K930507 · HTS
Associated Medical Products Co.
Orthopedic · 386d
Cleared Feb 22, 1994
MEGABOND SYSTEM
K930583 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 383d
Cleared Feb 22, 1994
MAGNACORE
K930584 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 383d
Cleared Feb 22, 1994
AUTOVAC CLOSED WOUND SUCTION SYSTEM
K930615 · GCY
Boehringer Laboratories
General & Plastic Surgery · 382d