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
85753–85776 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1999
TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE
K990761 · FRG
Tuttnauer U.S.A Co, Ltd.
General Hospital · 123d
Cleared Jul 09, 1999
SERUM CROSSLAPS ONE STEP ELISA
K990843 · JMM
Osteometer Biotech A/S
Chemistry · 116d
Cleared Jul 09, 1999
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
K991222 · GWM
Johnson & Johnson Professionals, Inc.
Neurology · 88d
Cleared Jul 09, 1999
ETCHING GEL
K991450 · EBF
Silicon-Und Composite Spezialitaten GmbH
Dental · 74d
Cleared Jul 09, 1999
GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K991554 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 67d
Cleared Jul 09, 1999
EPTFE RINGED GORE-TEX VASCULAR GRAFT
K991602 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 60d
Cleared Jul 09, 1999
CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700...
K991605 · GKZ
Abbott Laboratories
Hematology · 60d
Cleared Jul 09, 1999
POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES
K991624 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 59d
Cleared Jul 09, 1999
ACRON MC MODIFICATION
K991774 · EBI
GC America, Inc.
Dental · 45d
Cleared Jul 09, 1999
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
K991789 · LBR
Elan Holdings, Inc.
Chemistry · 45d
Cleared Jul 09, 1999
OPTIBOND SOLO PLUS 2
K991808 · KLE
Sybron Dental Specialties, Inc.
Dental · 43d
Cleared Jul 08, 1999
VIEWPOINT TOOLS- STERRAD
K983764 · HAW
Philips Medical Systems (Cleveland),...
Neurology · 255d
Cleared Jul 08, 1999
ATLAS MONITOR
K984033 · DRT
Welch Allyn, Inc.
Cardiovascular · 238d
Cleared Jul 08, 1999
QUALISYS PSA IMMUNOASSAY
K990234 · LTJ
Qualisys Diagnostics, Inc.
Immunology · 164d
Cleared Jul 08, 1999
STAINLESS STEEL SOFT SUTURE WIRE
K990355 · LRN
Bregma International Trading Company...
Orthopedic · 153d
Cleared Jul 08, 1999
EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM
K991211 · DXH
Reynolds Medical , Ltd.
Cardiovascular · 90d
Cleared Jul 08, 1999
MTI 1 ML SYRINGE
K991225 · FMF
Micro Therapeutics, Inc.
General Hospital · 87d
Cleared Jul 08, 1999
SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP...
K991235 · KXO
Ludlow Technical Products
Obstetrics & Gynecology · 87d
Cleared Jul 08, 1999
FCI CRAWFORD PROBE INTUBATION SETS
K991238 · OKS
Fci Ophthalmics, Inc.
Ophthalmic · 87d
Cleared Jul 08, 1999
THERMOPLATE
K991263 · MQG
Tokai Hit Co., Ltd.
Obstetrics & Gynecology · 86d
Cleared Jul 08, 1999
SPERM MAINTENANCE MEDIUM WITH GLYCEROL
K991337 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 80d
Cleared Jul 08, 1999
ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION
K991341 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 80d
Cleared Jul 08, 1999
PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION
K991342 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 80d
Cleared Jul 08, 1999
ISOLUX SURGICAL HEADLIGHT
K991572 · FST
Isolux America
General & Plastic Surgery · 64d