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
82825–82848 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 2000
CSM STRETTA SYSTEM
K000245 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 82d
Cleared Apr 18, 2000
SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST
K000400 · DKZ
Drug Detection Devices, Ltd.
Toxicology · 71d
Cleared Apr 18, 2000
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
K000402 · LCM
Drug Detection Devices, Ltd.
Toxicology · 71d
Cleared Apr 18, 2000
MEDTRADE PRODUCTS ALGINATE ISLAND
K000487 · KGN
Medtrade Products , Ltd.
General & Plastic Surgery · 64d
Cleared Apr 18, 2000
THERMOFLEX SYSTEM
K000508 · KNS
Argomed, Inc.
Gastroenterology & Urology · 63d
Cleared Apr 18, 2000
SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST
K000522 · DIS
Drug Detection Devices, Ltd.
Toxicology · 62d
Cleared Apr 18, 2000
GE LOGIQ 700
K000571 · IYO
GE Medical Systems
Radiology · 56d
Cleared Apr 18, 2000
QUIK-CAP
K000865 · GXY
Neuroscan
Neurology · 32d
Cleared Apr 18, 2000
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
K000874 · JJW
Bio-Rad
Chemistry · 29d
Cleared Apr 18, 2000
SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE...
K000876 · MNI
Interpore Cross Intl.
Orthopedic · 29d
Cleared Apr 18, 2000
PARA 12 PLUS RETICS
K000945 · GLQ
Streck Laboratories, Inc.
Hematology · 26d
Cleared Apr 18, 2000
MODIFICATION TO TSRH SPINAL SYSTEM
K000991 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 21d
Cleared Apr 18, 2000
I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
K001154 · JGS
I-Stat Corp.
Chemistry · 8d
Cleared Apr 18, 2000
NUVASIVE TOWNLEY FACET SCREW
K994308 · MRW
Nuvasive, Inc.
Orthopedic · 119d
Cleared Apr 17, 2000
DRG AURICA ELISA TESTOSTERONE KIT
K000043 · CDZ
Drg Intl., Inc.
Chemistry · 102d
Cleared Apr 17, 2000
ENHANCED COMPENSATING FILTER
K000137 · IXI
Computerized Medical Systems, Inc.
Radiology · 90d
Cleared Apr 17, 2000
FLUROPERM 60-OK, PARAGON HDS-OK
K000224 · MUW
Paragon Vision Sciences
Ophthalmic · 84d
Cleared Apr 17, 2000
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
K000398 · GGP
Shield Diagnostics, Ltd.
Hematology · 70d
Cleared Apr 17, 2000
RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE
K000406 · BXQ
Rhino Metrics A/S
Anesthesiology · 70d
Cleared Apr 17, 2000
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000458 · JXM
Dade Behring, Inc.
Toxicology · 66d
Cleared Apr 17, 2000
SPIFE CHOLESTEROL PROFILE KIT
K000603 · JHO
Helena Laboratories
Chemistry · 54d
Cleared Apr 17, 2000
STAT PROFILE PHOX PLUS ANALYZER
K000895 · JGS
Nova Biomedical Corp.
Chemistry · 28d
Cleared Apr 17, 2000
WILSON-COOK COLONIC Z-STENT
K990034 · MQR
Med Institute, Inc.
Gastroenterology & Urology · 467d
Cleared Apr 17, 2000
MEDLINE TENDER WET WOUND DRESSING
K991755 · MGQ
Medline Industries, Inc.
General & Plastic Surgery · 329d