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
98857–98880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1996
OSTEONICS N2/VAC PACKAGING PROCESS
K955421 · JWH
Osteonics Corp.
Orthopedic · 85d
Cleared Feb 21, 1996
ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM
K955531 · FAS
Arthrocare Corp.
Gastroenterology & Urology · 79d
Cleared Feb 21, 1996
RNS STERILE DISPOSABLE PUNCTURE TRAY
K955678 · FRG
Contour Fabricators of Florida, Inc.
General Hospital · 69d
Cleared Feb 21, 1996
RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
K955686 · FRG
Contour Fabricators of Florida, Inc.
General Hospital · 69d
Cleared Feb 21, 1996
RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY
K955688 · FRG
Contour Fabricators of Florida, Inc.
General Hospital · 69d
Cleared Feb 21, 1996
WINGED & SUBCUTANEOUS INFUSION SETS
K955709 · FPA
Distronic Sterile Products, Inc.
General Hospital · 65d
Cleared Feb 21, 1996
VENTED SOLUTION SET
K955732 · FPA
Distronic Sterile Products, Inc.
General Hospital · 64d
Cleared Feb 21, 1996
MED-NET STOPCOCKS
K955782 · FMG
Mednet, Inc.
General Hospital · 62d
Cleared Feb 21, 1996
N PROTEIN STANDARS SY
K955857 · CZW
Behring Diagnostics, Inc.
Immunology · 56d
Cleared Feb 21, 1996
N/T PROTEIN CONTROL SY/L, M AND H
K955858 · JJY
Behring Diagnostics, Inc.
Immunology · 56d
Cleared Feb 21, 1996
ENDOSCOPIC NEEDLE DRIVER
K960011 · OCW
United States Surgical, A Division of...
Gastroenterology & Urology · 50d
Cleared Feb 21, 1996
ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL
K960122 · EBG
Wallace A. Erickson & Co.
Dental · 36d
Cleared Feb 21, 1996
G.E. STERILE, STANDARD BIOPSY TRAY
K960141 · FRG
GE Medical Systems
General Hospital · 36d
Cleared Feb 21, 1996
CONSENSUS 26MM COCRMO FEMORAL HEAD
K960151 · JDI
U.S. Medical Products, Inc.
Orthopedic · 41d
Cleared Feb 21, 1996
CONSENSUS 32MM COCRMO FEMORAL HEAD
K960156 · JDI
U.S. Medical Products, Inc.
Orthopedic · 41d
Cleared Feb 21, 1996
G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY
K960201 · FRG
GE Medical Systems
General Hospital · 36d
Cleared Feb 21, 1996
G.E. STERILE PUNCTURE TRAY
K960202 · FRG
GE Medical Systems
General Hospital · 36d
Cleared Feb 21, 1996
DEGUDENT LS
K960256 · EJT
Degussa Corp.
Dental · 34d
Cleared Feb 21, 1996
CONSENSUS 22MM COCRMO FEMORAL HEAD
K960339 · JDI
U.S. Medical Products, Inc.
Orthopedic · 28d
Cleared Feb 21, 1996
ALLRAP/SLIP-N-GRIP
K960352 · EFB
Dental Disposables Intl., Inc.
Dental · 27d
Cleared Feb 21, 1996
TOPAZ
K960399 · EJT
J.F. Jelenko & Co., Inc.
Dental · 23d
Cleared Feb 20, 1996
REVERSE OSMOSIS SYSTEM
K944493 · FIP
G.E.M. Water Systems
Gastroenterology & Urology · 525d
Cleared Feb 20, 1996
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP
K946055 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 449d
Cleared Feb 20, 1996
TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP
K950342 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 389d