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
150073–150096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1985
ANTI-ASPIRATION VALVE
K843748 · FPA
Travenol Laboratories, S.A.
General Hospital · 100d
Cleared Jan 03, 1985
AUTOLOADER II
K843779 · JQW
Electro-Nucleonics Laboratories, Inc.
Chemistry · 100d
Cleared Jan 03, 1985
STAT/PB REAGENT
K843839 · DOF
Tri-Tech, Inc.
Chemistry · 94d
Cleared Jan 03, 1985
FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL
K843917 · JAA
Afp Imaging Corp.
Radiology · 90d
Cleared Jan 03, 1985
ANGIOPLUS-S
K843972 · JAA
Oec-Diasonics, Inc.
Radiology · 84d
Cleared Jan 03, 1985
HOBBS MEDICAL POLYPECTOMY SNARE
K844074 · OCZ
Hobbs Medical, Inc.
Gastroenterology & Urology · 76d
Cleared Jan 03, 1985
MODIFIED C-DAK
K844185 · KOC
Cd Medical, Inc.
Gastroenterology & Urology · 66d
Cleared Jan 03, 1985
CALCIUM REAGENT FOR DEMAND ANALYZER
K844241 · CIC
Advanced Biomedical Methods, Inc.
Chemistry · 63d
Cleared Jan 03, 1985
CHOLESTEROL REAGENT FOR DEMAND ANALYZER
K844242 · CHH
Advanced Biomedical Methods, Inc.
Chemistry · 63d
Cleared Jan 03, 1985
TOTAL BILIRUBIN FOR DEMAND ANALYZER
K844243 · CIC
Advanced Biomedical Methods, Inc.
Chemistry · 63d
Cleared Jan 03, 1985
RAICHEM PHOSPHORUS REAGENT
K844316 · CEO
Reagents Applications, Inc.
Chemistry · 48d
Cleared Jan 03, 1985
ALBUMIN REAGENT FOR DEMAND ANALYZER
K844330 · CIX
Advanced Biomedical Methods, Inc.
Chemistry · 57d
Cleared Jan 03, 1985
TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER
K844331 · CEK
Advanced Biomedical Methods, Inc.
Chemistry · 57d
Cleared Jan 03, 1985
CREATININE REAGENT FOR DEMAND ANALYZER
K844332 · CGX
Advanced Biomedical Methods, Inc.
Chemistry · 57d
Cleared Jan 03, 1985
GEMCAL ENI REFERENCE SERUM
K844344 · JIX
Biocell Laboratories, Inc.
Chemistry · 55d
Cleared Jan 03, 1985
SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP
K844358 · HQF
Coherent Medical Group
Ophthalmic · 55d
Cleared Jan 03, 1985
ND:YAG LASER PULMONARY OBSTRUCTION
K844458
Endo Lase, Inc.
Cardiovascular · 49d
Cleared Jan 03, 1985
HOBBS MEDICAL/JAYCO ASPIRATION CATHETER
K844550 · OCX
Hobbs Medical, Inc.
Gastroenterology & Urology · 43d
Cleared Jan 03, 1985
HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT
K844551 · FCL
Gobbs Medical, Inc.
Gastroenterology & Urology · 43d
Cleared Jan 03, 1985
MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE
K844668 · HQF
Cooper Lasersonics, Inc.
Ophthalmic · 34d
Cleared Jan 03, 1985
MAGNIFYING SPECTACLES W/PLASTIC LENSES
K844716 · HOI
Gazelle Corp.
Ophthalmic · 30d
Cleared Jan 02, 1985
HYDROGLIDE SPRING GUIDE WIRES
K841926 · DQX
Argon Medical Corp.
Cardiovascular · 237d
Cleared Jan 02, 1985
FEMALE URINARY INCONTINENCE SYS
K843128 · KNX
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 146d
Cleared Jan 02, 1985
PTCA GUIDING CATHER
K844161 · DQO
Cordis Corp.
Cardiovascular · 71d