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
84481–84504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1999
ACID HEMOGLOBIN KIT
K992199 · JBD
Helena Laboratories
Hematology · 83d
Cleared Sep 21, 1999
PASCO MIC AND MIC/ID PANELS, VANCOMYCIN
K992296 · JWY
Pasco Laboratories, Inc.
Microbiology · 76d
Cleared Sep 21, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
K992423 · GKP
Dade Behring, Inc.
Hematology · 62d
Cleared Sep 21, 1999
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
K992440 · MID
Cogent Diagnotics , Ltd.
Immunology · 61d
Cleared Sep 21, 1999
MITEK MINI QUICKANCHOR PLUS
K992487 · HWC
Mitek Products
Orthopedic · 57d
Cleared Sep 21, 1999
BIOCHECK IGE ELISA, MODEL BC-1035
K992528 · DGC
Biocheck, Inc.
Immunology · 55d
Cleared Sep 21, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
K992763 · GKP
Dade Behring, Inc.
Hematology · 35d
Cleared Sep 21, 1999
CD HORIZON SPINAL SYSTEM
K992928 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 21d
Cleared Sep 21, 1999
CANNULATED SMARTSCREW MODELS 224540C, 224570C
K992947 · HWC
Bionx Implants, Ltd.
Orthopedic · 20d
Cleared Sep 21, 1999
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
K992963 · KXK
International Isotopes, Inc.
Radiology · 19d
Cleared Sep 20, 1999
STATVIEW SYSTEM
K990378 · MSX
Data Critical Corp.
Cardiovascular · 224d
Cleared Sep 20, 1999
AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES,...
K992124 · GMQ
Avanti Polar Lipids, Inc.
Microbiology · 89d
Cleared Sep 20, 1999
AMPLAID A724 AND A728
K992370 · ETY
Amplifon S.P.A.
Ear, Nose, Throat · 67d
Cleared Sep 20, 1999
HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010
K992559 · DTZ
Jostra Bentley
Cardiovascular · 52d
Cleared Sep 20, 1999
QUICKPAC II ONE STEP COCAINE TEST
K992990 · DIO
Syntron Bioresearch, Inc.
Toxicology · 13d
Cleared Sep 17, 1999
TENS/FES/NMES ELECTRODES
K983097 · GXY
Uni-Patch, Inc.
Neurology · 389d
Cleared Sep 17, 1999
@ TARGET
K983410 · HAW
Brainlab AG
Neurology · 354d
Cleared Sep 17, 1999
OLYMPUS DISTAL ATTACHMENT, MODELS...
K984358 · FDS
Olympus America, Inc.
Gastroenterology & Urology · 284d
Cleared Sep 17, 1999
BIOBUTTON
K990194 · HWC
Linvatec Corp.
Orthopedic · 239d
Cleared Sep 17, 1999
INSTRUMENT, ULTRASONIC, SCALPEL
K990362 · GEI
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 224d
Cleared Sep 17, 1999
CALTAG FETAL HEMOGLOBIN TEST
K990641 · GHQ
Caltag Laboratories, Inc.
Hematology · 203d
Cleared Sep 17, 1999
ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING
K990810 · FRO
Maersk Medical, Ltd.
General & Plastic Surgery · 190d
Cleared Sep 17, 1999
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
K991480 · CGA
Selfcare, Inc.
Chemistry · 142d
Cleared Sep 17, 1999
DRX QT. HCG
K991532 · DHA
Metrika, Inc.
Chemistry · 137d