FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76225–76248 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2002
BARBITURATES
K012996 · DIS
Abbott Laboratories
Toxicology · 195d
Cleared Mar 20, 2002
METHADONE
K013001 · DJR
Abbott Laboratories
Toxicology · 195d
Cleared Mar 20, 2002
PROPOXYPHENE
K013100 · JXN
Abbott Laboratories
Toxicology · 184d
Cleared Mar 20, 2002
RAPIDONE-OXY TEST
K014101 · DJG
American Bio Medica Corp.
Toxicology · 97d
Cleared Mar 20, 2002
SULZER DENTAL CERAMIC SYSTEM-HEXLOCK
K014175 · NHA
Sulzer Dental, Inc.
Dental · 90d
Cleared Mar 20, 2002
LATEX EXAMINATION GLOVES (POWDER FREE)
K014279 · LYY
Brightway Gloves Pvt. , Ltd.
General Hospital · 83d
Cleared Mar 20, 2002
LATEX EXAMINATION GLOVE (POWDERED)
K014280 · LYY
Brightway Gloves Pvt. , Ltd.
General Hospital · 83d
Cleared Mar 20, 2002
VISUALINE BARBITURATES DIPSTRIP TEST
K020136 · DIS
Sun Biomedical Laboratories, Inc.
Toxicology · 64d
Cleared Mar 20, 2002
TOUCH&BOND-PLUS
K020239 · KLE
Parkell, Inc.
Dental · 56d
Cleared Mar 20, 2002
DAVLITE MICROENDOSCOPE & ACCESSORIES
K020310 · GCJ
Davlite Technologies
General & Plastic Surgery · 50d
Cleared Mar 20, 2002
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC...
K020316 · DQO
Cordis Corp.
Cardiovascular · 49d
Cleared Mar 20, 2002
PASCO MIC AND MIC/ID PANELS
K020331 · JWY
Pasco Laboratories, Inc.
Microbiology · 48d
Cleared Mar 20, 2002
BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757
K020523 · SCL
Bd
General Hospital · 29d
Cleared Mar 20, 2002
PATIENTNET MONITORING SYSTEM
K020524 · MSX
General Electric Medical Systems...
Cardiovascular · 29d
Cleared Mar 20, 2002
PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A
K020531 · MHX
Philips Medical Systems
Cardiovascular · 29d
Cleared Mar 20, 2002
MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER
K020590 · FLE
Getinge/Castle, Inc.
General Hospital · 26d
Cleared Mar 20, 2002
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
K020660 · MEB
I-Flow Corp.
General Hospital · 19d
Cleared Mar 20, 2002
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
K020777 · MNS
Respironics, Inc.
Anesthesiology · 9d
Cleared Mar 19, 2002
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01
K010253 · DYG
Transonic Systems, Inc.
Cardiovascular · 417d
Cleared Mar 19, 2002
HEARTTRENDS
K012825 · DQK
Lev-El, Ltd.
Cardiovascular · 208d
Cleared Mar 19, 2002
INCARE PELVIC FLOOR THERAPY SYSTEM
K013612 · HIR
Hollister, Inc.
Gastroenterology & Urology · 134d
Cleared Mar 19, 2002
NELSON ELECTROSURGICAL UNIT, MODEL GN640
K014172 · GEI
Aesculap, Inc.
General & Plastic Surgery · 89d
Cleared Mar 19, 2002
KAYAK HYDROPHILIC GUIDE WIRES
K014195 · DOX
Boston Scientific Corp
Toxicology · 88d
Cleared Mar 19, 2002
SULZER DENTAL CERAMIC SYSTEM-SPLINE
K014214 · DZE
Sulzer Dental, Inc.
Dental · 88d