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
171001–171024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1978
STERILE INFUSION SET TYPE J
K780656 · FPA
Suru Chemicals & Pharmaceuticals, Ltd.
General Hospital · 90d
Cleared Jul 19, 1978
STERILE BLOOD COLLECTION SET
K780657 · FPA
Suru Chemicals & Pharmaceuticals, Ltd.
General Hospital · 90d
Cleared Jul 19, 1978
STERILE BLOOD ADMINISTRATION SET
K780658 · FPA
Suru Chemicals & Pharmaceuticals, Ltd.
General Hospital · 90d
Cleared Jul 18, 1978
DIGITAL BLOOD PRESSURE MONITOR
K780986 · DXN
Sears, Roebuck & Co.
Cardiovascular · 34d
Cleared Jul 18, 1978
CT SCANNER ND 8000
K781040 · JAK
Cgr Medical Corp.
Radiology · 28d
Cleared Jul 18, 1978
THERAPAX 150A
K781084 · JAD
Emi Therapy Systems, Inc.
Radiology · 19d
Cleared Jul 17, 1978
SILASTIC BRAND PENILE IMPLANT
K780484 · FIQ
Dow Corning Corp. Healthcare...
Gastroenterology & Urology · 112d
Cleared Jul 17, 1978
SUTURE CUTTER
K780574 · FZT
Laschal Instrument Corp.
General & Plastic Surgery · 98d
Cleared Jul 17, 1978
LUNDIA PLATE DISPOSABLE DIALYZER
K780700 · FJG
Gambro, Inc.
Gastroenterology & Urology · 82d
Cleared Jul 17, 1978
CUFF PACER
K780703 · CBA
Omp Laboratories, Inc.
Anesthesiology · 83d
Cleared Jul 17, 1978
AUTOMATIC RETRACTOR HOLDER
K780708 · GAD
Great Eastern Lumber Co., Inc.
General & Plastic Surgery · 83d
Cleared Jul 17, 1978
ANEROID TYPE BLOOD PRESSURE KIT
K780715 · DXQ
Mars Metal Co., Ltd.
Cardiovascular · 81d
Cleared Jul 17, 1978
PENTAX ST-1A
K780738 · DQD
Hal-Hen Co., Inc.
Cardiovascular · 76d
Cleared Jul 17, 1978
PERCUTANEOUS SURAPUBIC CATHETER
K780765 · KOB
Vance Products, Inc.
Gastroenterology & Urology · 73d
Cleared Jul 17, 1978
PERCI
K780838 · BXX
Micro Tronics Corp.
Anesthesiology · 56d
Cleared Jul 17, 1978
SLICK SET
K780900 · BTR
Polamedco, Inc.
Anesthesiology · 63d
Cleared Jul 17, 1978
BARD-PARKER ARTERIAL MONITORING SYSTEM
K780939 · CBT
Bd Becton Dickinson Vacutainer...
Anesthesiology · 39d
Cleared Jul 17, 1978
PVC QUICK PRIME LINES
K780984 · KRI
Norton Performance Plastics Corp.
Cardiovascular · 33d
Cleared Jul 17, 1978
X-RAY UNIT, PORTABLE GX-101 AEC
K781030 · IZL
General X-Ray, Inc.
Radiology · 28d
Cleared Jul 17, 1978
EMISONIC 4201
K781051 · IYO
Emi Medical, Inc.
Radiology · 25d
Cleared Jul 17, 1978
FACE TENTS
K781055 · BYG
Hospitak, Inc.
Anesthesiology · 24d
Cleared Jul 17, 1978
CLINAC 20 (OPTIONAL 18 MV VERSION)
K781057 · IYE
Varian Assoc., Inc.
Radiology · 24d
Cleared Jul 17, 1978
PLURIMAT
K781065 · IYB
Tecnomed, Inc.
Radiology · 21d
Cleared Jul 17, 1978
PLURIX C
K781066 · IXQ
Tecnomed, Inc.
Radiology · 21d