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
108889–108912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1994
KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION
K936138 · JHI
Eastman Kodak Company
Chemistry · 106d
Cleared Apr 08, 1994
KODAK SURECELL HCG URINE TEST, MODIFICATION
K936287 · JHI
Eastman Kodak Company
Chemistry · 106d
Cleared Apr 08, 1994
LIQUID LIGHT 500
K940962 · FFS
Incredivision, Inc.
Gastroenterology & Urology · 37d
Cleared Apr 08, 1994
XENON LIGHT SOURCE
K940963 · FFS
Incredivision, Inc.
Gastroenterology & Urology · 37d
Cleared Apr 07, 1994
ALLEGRO VIEWING WAND
K911783 · LLZ
I.S.G. Technologies, Inc.
Radiology · 1081d
Cleared Apr 07, 1994
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K924985 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 553d
Cleared Apr 07, 1994
ZEST ANCHOR ADVANCED GENERATION
K925700 · EGG
Zest Anchors, Inc.
Dental · 511d
Cleared Apr 07, 1994
NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE
K926021 · HET
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 493d
Cleared Apr 07, 1994
AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR
K930320 · KYB
Allergan Medical Optics
Ophthalmic · 440d
Cleared Apr 07, 1994
ONECATH L-CATH CATHETER SYSTEM
K930473 · LJS
Luther Medical Products, Inc.
General Hospital · 434d
Cleared Apr 07, 1994
SYNVASIVE CERAMIC SUTTING BLOCK
K930573 · LXI
Synvasive Technology, Inc.
Orthopedic · 427d
Cleared Apr 07, 1994
VERRSS PNEUMO NEEDLE
K931850 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 359d
Cleared Apr 07, 1994
CMI E-Z FLO BULB P.N. 701
K932128 · FFY
Columbia Medical & Surgical, Inc.
Gastroenterology & Urology · 339d
Cleared Apr 07, 1994
DIGITAL DISK RECORDER
K933115 · LMB
Eigen
Radiology · 286d
Cleared Apr 07, 1994
SHARPLAN CO2 SURGICAL LASER
K933362 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 272d
Cleared Apr 07, 1994
DVFX, MODEL M256
K933460 · IZI
Xre Corp.
Radiology · 265d
Cleared Apr 07, 1994
TOP GUN
K933742 · FQH
Bio-Medical Devices, Inc.
General Hospital · 247d
Cleared Apr 07, 1994
MOBILE SOPHIE MODIFICATION
K934373 · IZH
Planmed OY
Radiology · 211d
Cleared Apr 07, 1994
SOFTTOUCH GUIDE CATHETER
K934685 · DQY
Mallinckrodt Medical
Cardiovascular · 189d
Cleared Apr 07, 1994
HANDI-FOAM
K935021 · IYE
Medtec, Inc.
Radiology · 169d
Cleared Apr 07, 1994
MITEK MODULAR DRILL BIT
K935225 · GFG
Mitek Surgical Products, Inc.
General & Plastic Surgery · 157d
Cleared Apr 07, 1994
COMB-18 WOUND DRESSING
K936193 · KMF
Vsc Health Care Products
General & Plastic Surgery · 101d
Cleared Apr 07, 1994
AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE DEVICE II
K940398 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 70d
Cleared Apr 07, 1994
KALTOGEL WOUND DRESSING
K940407 · KMF
Calgon Corp.
General & Plastic Surgery · 70d