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
109609–109632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1994
IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER
K926305 · DZE
The Stern Metals Co., Inc.
Dental · 441d
Cleared Mar 01, 1994
BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
K926479 · GCJ
Davol, Inc.
General & Plastic Surgery · 427d
Cleared Mar 01, 1994
POST-MYDS(TM)
K930840 · HOY
Aukland Medical Plastics, Inc.
Ophthalmic · 377d
Cleared Mar 01, 1994
SENSING TIP SURGICAL TROCAR
K930848 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 376d
Cleared Mar 01, 1994
TICK-ATTACK(TM) KIT
K931058 · LRR
Mind Mechanics, Inc.
General & Plastic Surgery · 365d
Cleared Mar 01, 1994
INFINITECH OTOPROBE
K931264 · GEX
Infinitech, Inc.
General & Plastic Surgery · 358d
Cleared Mar 01, 1994
FULLY THREADED ALTA CANCELLOUS BONE SCREW
K931524 · HWC
Howmedica Corp.
Orthopedic · 340d
Cleared Mar 01, 1994
HGM ILLUMINATING IMAGING ENDOCULAR PROBE
K931784 · HQF
Hgm, Inc.
Ophthalmic · 326d
Cleared Mar 01, 1994
BIOMIC VIDEO PLATE READER
K932122 · KZK
Giles Scientific, Inc.
Microbiology · 302d
Cleared Mar 01, 1994
ORTHOPEDIC SMOOTH PIN FIXATION
K932348 · HTY
Osteomed Corp.
Orthopedic · 291d
Cleared Mar 01, 1994
ORTHOPEDIC THREADED PIN FIXATION
K932349 · JDW
Osteomed Corp.
Orthopedic · 291d
Cleared Mar 01, 1994
EXCEL'S EST-30 HO:YAG LASER SYSTEM
K932730 · GEX
Excel Tech. , Ltd.
General & Plastic Surgery · 267d
Cleared Mar 01, 1994
RIVER VIAL ADAPTER
K933335 · FMF
River Medical, Inc.
General Hospital · 236d
Cleared Mar 01, 1994
R AND D BATTERIES, INC. PART NUMBER 5017
K933449 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 231d
Cleared Mar 01, 1994
DIOMED 25 25W SURGICAL DIODE LASER
K933525 · GEX
Dio-Med Corp.
General & Plastic Surgery · 223d
Cleared Mar 01, 1994
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN...
K933713 · DTN
Baxter Healthcare Corp
Cardiovascular · 214d
Cleared Mar 01, 1994
PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE
K933875 · JDI
Howmedica Corp.
Orthopedic · 204d
Cleared Mar 01, 1994
STERILE CENTRAL LINE DRESSING TRAY
K934031 · FRG
Surgipro, Inc.
General Hospital · 196d
Cleared Mar 01, 1994
ADULT ANESTHESIA BREATHING CIRCUIT KITS
K934462 · CAI
Zefon Medical Products
Anesthesiology · 169d
Cleared Mar 01, 1994
SPECTACLE FRAMES
K934570 · HQZ
Chaser Optical Corp.
Ophthalmic · 166d
Cleared Mar 01, 1994
STAGO FACTOR V-DEFICIENT PLASMA
K934605 · GJT
American Bioproducts Co.
Hematology · 155d
Cleared Mar 01, 1994
STAGO FACTOR II-DEFICIENT PLASMA
K934606 · GJT
American Bioproducts Co.
Hematology · 155d
Cleared Mar 01, 1994
PUNCTURE CLOSURE DEVICE
K934807 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 145d
Cleared Mar 01, 1994
MARTINEZ ORBITAL IMPLANT
K935251 · HPZ
Miguel Martinez M.D.
Ophthalmic · 120d