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
92689–92712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1997
MOMO DESIGN OR MOMO
K972416 · HQY
Momo U.S.A., Inc.
Ophthalmic · 24d
Cleared Jul 20, 1997
BUN (LIQUID) REAGENT SET
K972671 · CDQ
Pointe Scientific, Inc.,
Chemistry · 4d
Cleared Jul 18, 1997
MODIFIED PEDIKAIR
K954320 · FNM
Kinetic Concepts, Inc.
General Hospital · 680d
Cleared Jul 18, 1997
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
K961392 · FJS
Sil-Med Corp.
Gastroenterology & Urology · 463d
Cleared Jul 18, 1997
STERILE AMBULATORY RESERVOIR 60ML/100ML
K962159 · MRZ
Faulding Medical Device Co.
General Hospital · 409d
Cleared Jul 18, 1997
PULSE*SPRAY INJECTOR
K963574 · FRN
AngioDynamics, Inc.
General Hospital · 315d
Cleared Jul 18, 1997
CARDIOMAGIC 2000 SOFTWARE
K964036 · DXH
Instromedix, Inc.
Cardiovascular · 283d
Cleared Jul 18, 1997
ISOLYSER SDS SHARPS CONTAINER
K970547 · FMI
Thantex Specialties, Inc.
General Hospital · 156d
Cleared Jul 18, 1997
CRYO CHECK FACTOR IX DEFICIENT PLASMA
K971226 · GJT
Precision Biologicals, Inc.
Hematology · 107d
Cleared Jul 18, 1997
CRYO CHECK FACTOR X DEFICIENT PLASMA
K971227 · GJT
Precision Biologicals, Inc.
Hematology · 107d
Cleared Jul 18, 1997
AESCULAP JET IRRIGATION SYSTEM
K971310 · GEI
Aesculap, Inc.
General & Plastic Surgery · 101d
Cleared Jul 18, 1997
3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160)
K971446 · GEI
3M Company
General & Plastic Surgery · 88d
Cleared Jul 18, 1997
DERMALASE
K971459 · GEX
Endo Technic Corp.
General & Plastic Surgery · 88d
Cleared Jul 18, 1997
DURALASTIC ANATOMICAL CHIN IMPLANTS
K971478 · FWP
Allied Biomedical Corp.
General & Plastic Surgery · 86d
Cleared Jul 18, 1997
DURALASTIC ANATOMICAL MALAR IMPLANTS
K971479 · LZK
Allied Biomedical Corp.
General & Plastic Surgery · 86d
Cleared Jul 18, 1997
DURALASTIC ANATOMICAL NASAL IMPLANTS
K971481 · FZE
Allied Biomedical Corp.
General & Plastic Surgery · 86d
Cleared Jul 18, 1997
REST MATTRESS
K971568 · FNM
Rest Mattress
General Hospital · 80d
Cleared Jul 18, 1997
CORDIS OPTA 5 PTA BALLOON CATHETER
K971579 · LIT
Cordis Corp.
Cardiovascular · 88d
Cleared Jul 18, 1997
HEMISPHERE CEMENTED CUP
K971581 · JDI
Ortho Development Corp.
Orthopedic · 79d
Cleared Jul 18, 1997
STERICHEK CHLORINE REAGENT STRIPS
K971598 · MSY
Environmental Test Systems, Inc.
Gastroenterology & Urology · 78d
Cleared Jul 18, 1997
SHARPLAN CO2 SURGICAL LASER SYSTEM
K971743 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 67d
Cleared Jul 18, 1997
SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM
K971783 · HTY
Synthes (Usa)
Orthopedic · 65d
Cleared Jul 18, 1997
ATLAS FRACTURE PROXIMAL HUMERAL NAIL
K971816 · HSB
Biomet, Inc.
Orthopedic · 63d
Cleared Jul 18, 1997
BREATH ACE BREATHFRESHENER
K972131 · LCN
Beyond 21st Century, Inc.
Dental · 42d