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
102265–102288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1995
INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL
K952453 · ESD
Argosy Electronics
Ear, Nose, Throat · 27d
Cleared Jun 21, 1995
EXPANDER WITH ACTIVE TONE CONTROL
K952454 · ESD
Argosy Electronics
Ear, Nose, Throat · 27d
Cleared Jun 21, 1995
IMPROVED MANHATTAN II
K952455 · ESD
Argosy Electronics
Ear, Nose, Throat · 27d
Cleared Jun 20, 1995
SIMMONS PLATING SYSTEM BOLT AND SCREW
K930353 · MNH
Smith & Nephew, Inc.
Orthopedic · 880d
Cleared Jun 20, 1995
CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES
K944126 · GKZ
Caltag Laboratories, Inc.
Hematology · 301d
Cleared Jun 20, 1995
CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY
K944127 · GKZ
Caltag Laboratories, Inc.
Hematology · 301d
Cleared Jun 20, 1995
CALTAG CD4 R-PE MONOCLONAL ANTIBODY
K944128 · GKZ
Caltag Laboratories, Inc.
Hematology · 301d
Cleared Jun 20, 1995
AURAFLEX B2-MICROGLOBULIN
K944846 · JZG
Organon Teknika Corp.
Immunology · 263d
Cleared Jun 20, 1995
SCHOLAR PATIENT MONITOR
K944860 · MHX
Criticare Systems, Inc.
Cardiovascular · 260d
Cleared Jun 20, 1995
BOBES TONOMETER
K945446 · HKY
Bobes S.A.
Ophthalmic · 225d
Cleared Jun 20, 1995
1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES
K945836 · DRX
Conmed Andover Medical, Inc.
Cardiovascular · 203d
Cleared Jun 20, 1995
CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY
K951169 · LGS
Ciba Corning Diagnostics Corp.
Chemistry · 97d
Cleared Jun 20, 1995
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300
K951259 · CAF
Impulso Trading Co.
Anesthesiology · 91d
Cleared Jun 20, 1995
NEZHAT-DORSEY THERMAL RETENTION SYSTEM
K951300 · LHC
American Hydro-Surgical Instruments,...
General Hospital · 90d
Cleared Jun 20, 1995
CARBOMEDICS EXENDED MITRAL ROTATOR
K951368 · MOP
Carbomedics, Inc.
Cardiovascular · 85d
Cleared Jun 20, 1995
CEDIA DAU BENZODIAZEPINE ASSAY
K951710 · JXM
Microgenics Corp.
Toxicology · 67d
Cleared Jun 20, 1995
IMNI-II
K951983 · LRJ
Cottrell, Ltd.
General Hospital · 54d
Cleared Jun 20, 1995
MS EMULSION
K952123 · KLE
Parkell, Inc.
Dental · 46d
Cleared Jun 20, 1995
ABOND
K952124 · KLE
Parkell, Inc.
Dental · 46d
Cleared Jun 20, 1995
ORGENTEC ANTI-TPO ELISA
K952129 · JZO
American Laboratory Products Co., Ltd.
Immunology · 43d
Cleared Jun 20, 1995
ORGENTEC ANTI-TG ELISA
K952130 · JZO
American Laboratory Products Co., Ltd.
Immunology · 43d
Cleared Jun 20, 1995
SYNERMED ISE REAGENTS
K952179 · JGS
Synermed, Inc.
Chemistry · 42d
Cleared Jun 20, 1995
TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT
K952246 · JXA
Tri-Tech, Inc.
Chemistry · 39d
Cleared Jun 20, 1995
AMERLITE FERRITIN II ASSAY
K952286 · DBF
Johnson & Johnson Clinical...
Immunology · 35d