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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
125617–125640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1990
DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE
K901428 · FDI
Telemed Systems, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 18, 1990
TELEMED ERCP CANNULA
K901431 · FGE
Telemed Systems, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 18, 1990
BRONCHIAL CYTOLOGY BRUSH
K901436 · FDX
Telemed Systems, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 18, 1990
TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE
K901437 · FBK
Telemed Systems, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 18, 1990
ZIMMON PAPILLOTOME
K901443 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Jun 18, 1990
CUDA SURGICAL LIGHT
K901491 · FST
Cuda Products Co.
General & Plastic Surgery · 81d
Cleared Jun 18, 1990
SAF-T CLIK I.V. IN-LINE CONNECTOR & EXTENSION SET
K901729 · FPA
Ryan Medical, Inc.
General Hospital · 63d
Cleared Jun 18, 1990
LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25
K901809 · GXY
Lumiscope Co., Inc.
Neurology · 59d
Cleared Jun 18, 1990
WAKO(TM) MICRO-ALBUMIN
K902216 · JIQ
Wako Chemicals USA, Inc.
Chemistry · 33d
Cleared Jun 18, 1990
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
K902259 · JWX
Orthomet, Inc.
Microbiology · 28d
Cleared Jun 18, 1990
CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE
K902336 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 25d
Cleared Jun 18, 1990
MODIFIED DELFIA ESTRADIOL KIT
K902358 · CHP
Pharmacia, Inc.
Chemistry · 20d
Cleared Jun 18, 1990
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K902380 · KGO
Baxter Healthcare Corp
General Hospital · 19d
Cleared Jun 15, 1990
BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT
K900546 · GTH
Baxter Healthcare Corp
Microbiology · 130d
Cleared Jun 15, 1990
WATER PIK(R) W/ADD'L CLAIMS
K900547 · EFS
Teledyne Water Pik
Dental · 130d
Cleared Jun 15, 1990
DOBBHOFF(R) POLYPECTOMY SNARE
K901322 · FDI
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 86d
Cleared Jun 15, 1990
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
K901414 · LCP
Helena Laboratories
Hematology · 81d
Cleared Jun 15, 1990
FORMASIL(R)A POLYVINYL SILOXANE LINE
K901681 · ELW
Kulzer, Inc.
Dental · 65d
Cleared Jun 15, 1990
SILISTOR CERAMIC AND RESIN REPAIR SYSTEM
K901697 · EBF
Kulzer, Inc.
Dental · 66d
Cleared Jun 15, 1990
ZEFAZONE SUSCEPTIBILITY TEST DISKS
K902082 · JTN
Difco Laboratories, Inc.
Microbiology · 38d
Cleared Jun 15, 1990
CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE
K902083 · GJT
Helena Laboratories
Hematology · 39d
Cleared Jun 14, 1990
DANEK PRECISION ROD SET
K896254 · KWP
Danek Medical, Inc.
Orthopedic · 227d
Cleared Jun 14, 1990
CARAGLAS XTRA SYNTHETIC CASTING TAPE
K896634 · LGF
Buckman Co., Inc.
Orthopedic · 204d
Cleared Jun 14, 1990
FRAME, SPECTACLE
K897091 · HQZ
Pt Midas Surya Optical Co.
Ophthalmic · 176d