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
99841–99864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1995
BD PERISAFE EPIDURAL ANESTHESIA TRAY
K953790 · CAZ
Bd Becton Dickinson Vacutainer...
Anesthesiology · 108d
Cleared Nov 30, 1995
DAVIS & GECK LIGATING CLIP REMOVER
K953908 · FZP
Davis & Geck, Inc.
General & Plastic Surgery · 101d
Cleared Nov 30, 1995
SYNTHASIL APTT REAGENT
K953981 · GFO
Ortho Diagnostic Systems, Inc.
Hematology · 99d
Cleared Nov 30, 1995
EXTEND HIP SYSTEM
K954288 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Nov 30, 1995
PVC ABDOMINAL/RECTAL PRESSURE CATHETER
K954315 · FEN
Life-Tech Intl., Inc.
Gastroenterology & Urology · 76d
Cleared Nov 30, 1995
OSTEONICS UNIPOLAR ENDO HEAD
K954534 · KWL
Osteonics Corp.
Orthopedic · 62d
Cleared Nov 30, 1995
STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)
K954711 · CHL
Nova Biomedical Corp.
Chemistry · 63d
Cleared Nov 30, 1995
SPLASH & GO II
K955295 · IOR
Kid'S Wheel-Chairs
Physical Medicine · 14d
Cleared Nov 29, 1995
BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE
K930181 · FKP
Fresenius USA, Inc.
Gastroenterology & Urology · 1049d
Cleared Nov 29, 1995
9267 SPO2 ATHENA MODULE
K940933 · DQA
S & W Medico Teknik
Anesthesiology · 639d
Cleared Nov 29, 1995
DRS 4 ND DIALYZER REPROCESSING SYSTEM
K944539 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 440d
Cleared Nov 29, 1995
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
K944767 · FIP
Fresenius USA, Inc.
Gastroenterology & Urology · 428d
Cleared Nov 29, 1995
AM RUBY
K950826 · GEX
American Lasers, Inc.
General & Plastic Surgery · 279d
Cleared Nov 29, 1995
DISPOSABLE SYRINGE
K950969 · FMF
Surgiplast , Ltd.
General Hospital · 272d
Cleared Nov 29, 1995
OPTILITE VIII LASER SURGERY ACCESSORIES
K951760 · GEX
Xintec Corporation
General & Plastic Surgery · 226d
Cleared Nov 29, 1995
CARBOMEDICS SUPRA-ANNULAR VALVE SIZER
K952184 · DTI
Carbomedics, Inc.
Cardiovascular · 204d
Cleared Nov 29, 1995
VANGATOR II
K952946 · ING
Crow River Industries, Inc.
Physical Medicine · 156d
Cleared Nov 29, 1995
STRATO/INFUSAID INFUSE-A-KIT
K953254 · LJT
Strato/Infusaid, Inc.
General Hospital · 140d
Cleared Nov 29, 1995
PROTEAM CUSHION
K953352 · KIC
Iskra.Med
Physical Medicine · 135d
Cleared Nov 29, 1995
CLS ACETABULAR COMPONENT (MODIFICATION)
K953688 · LZO
Intermedics Orthopedics
Orthopedic · 121d
Cleared Nov 29, 1995
WAGNER REVISION STEM (MODIFICATION)
K953689 · LZO
Intermedics Orthopedics
Orthopedic · 121d
Cleared Nov 29, 1995
INTROSCOPE
K953793 · BZT
Polamedco, Inc.
Anesthesiology · 107d
Cleared Nov 29, 1995
MLT 20
K953800 · GEX
Medical Laser Technology, Inc.
General & Plastic Surgery · 107d
Cleared Nov 29, 1995
SPYROFLEX SKIN PROTECTOR
K953885 · MGP
Polymedica Industries, Inc.
General & Plastic Surgery · 104d