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
87481–87504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1998
PERIFORM
K981277 · HIR
Verimed Holdings, Inc.
Gastroenterology & Urology · 226d
Cleared Nov 20, 1998
SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM
K981530 · BSZ
Spacelabs Medical, Inc.
Anesthesiology · 205d
Cleared Nov 20, 1998
NEUROMAP
K981820 · GZL
Radionics, Inc.
Neurology · 182d
Cleared Nov 20, 1998
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
K981975 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 168d
Cleared Nov 20, 1998
STERI-PAK BOWIE DICK TEST PACK
K982188 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 151d
Cleared Nov 20, 1998
AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
K982759 · DIO
OraSure Technologies, Inc.
Toxicology · 106d
Cleared Nov 20, 1998
ZETA MULTIZONE LOCKING NAIL SYSTEM
K982958 · HSB
Howmedica Corp.
Orthopedic · 88d
Cleared Nov 20, 1998
POLYMER THREADED ANCHOR / SUTURE COMBINATION
K982963 · JDI
Orthopaedic Biosystems, Ltd.
Orthopedic · 88d
Cleared Nov 20, 1998
SYSTEM U3 FOR GENTAMICIN
K983252 · JWY
Ab Biodisk North America, Inc.
Microbiology · 65d
Cleared Nov 20, 1998
PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT
K983253 · LCP
Medisense, Inc.
Hematology · 65d
Cleared Nov 20, 1998
MODIFICATION TO PORTABLE INTENSIVE CARE UNIT
K983307 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 60d
Cleared Nov 20, 1998
ABBOTT ARCHITECT FREE T4
K983417 · CEC
Abbott Laboratories
Chemistry · 52d
Cleared Nov 20, 1998
ABBOTT ARCHITECT TOTAL T3
K983434 · CDP
Abbott Laboratories
Chemistry · 52d
Cleared Nov 20, 1998
ABBOTT ARCHITECT FREE T3
K983439 · CDP
Abbott Laboratories
Chemistry · 52d
Cleared Nov 20, 1998
ABBOTT ARCHITECT TSH
K983442 · JLW
Abbott Laboratories
Chemistry · 51d
Cleared Nov 20, 1998
STANDARD CHIN
K983754 · FWP
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 29d
Cleared Nov 20, 1998
NASAL DORSAL SERIES
K983755 · FZE
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 29d
Cleared Nov 20, 1998
SURGIFORM ANATOMICAL MALAR
K983756 · LZK
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 29d
Cleared Nov 20, 1998
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · FRN
Abbott Laboratories
General Hospital · 30d
Cleared Nov 20, 1998
BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO...
K983981 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 11d
Cleared Nov 20, 1998
ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05
K984074 · JJY
Bio-Rad
Chemistry · 4d
Cleared Nov 19, 1998
ASTRA TECH IMPLANT DENTAL SYSTEM
K974738 · DZE
Astra Tech, Inc.
Dental · 335d
Cleared Nov 19, 1998
FACTS
K982010 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 164d
Cleared Nov 19, 1998
CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615
K982243 · CAW
Canogen International , Ltd.
Anesthesiology · 147d