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
85945–85968 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1999
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
K990138 · LOJ
Diagnostic Systems Laboratories, Inc.
Immunology · 153d
Cleared Jun 21, 1999
SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
K990186 · LZA
Shanghai Intco. Plastic & Rubber...
General Hospital · 152d
Cleared Jun 21, 1999
QUANTASE TOTAL GALACTOSE SCREENING ASSAY
K990644 · JIA
Quantase , Ltd.
Chemistry · 115d
Cleared Jun 21, 1999
QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
K990654 · JIA
Quantase , Ltd.
Chemistry · 112d
Cleared Jun 21, 1999
MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM...
K991153 · LYY
Medtexx Industries (Thai) Co. , Ltd.
General Hospital · 76d
Cleared Jun 21, 1999
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES
K991155 · LYY
C.V. Anlis Abadi International
General Hospital · 76d
Cleared Jun 21, 1999
C-FLEX URETERAL STENTS
K991219 · FAD
Applied Medical Resources
Gastroenterology & Urology · 70d
Cleared Jun 21, 1999
HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES
K991305 · LYY
M.R.G. Industries Sdn. Bhd.
General Hospital · 66d
Cleared Jun 21, 1999
PACIFIC HEMOSTASIS THROMBOSCREEN 200
K991321 · KQG
Pacific Hemostasis
Hematology · 63d
Cleared Jun 21, 1999
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15...
K991362 · JBD
Morax
Hematology · 68d
Cleared Jun 21, 1999
DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE...
K991402 · GKZ
Dako Corp.
Hematology · 60d
Cleared Jun 21, 1999
MOUSE IGG1 NEGATIVE CONTROLS
K991454 · GKZ
Dako Corp.
Hematology · 56d
Cleared Jun 21, 1999
TENDER TOUCH SILICONE GEL PADS
K991478 · MDA
Capital Marketing Technologies, Inc.
General & Plastic Surgery · 54d
Cleared Jun 21, 1999
SELF CURE COMPOSITE
K991488 · EBF
Harry J. Bosworth Co.
Dental · 54d
Cleared Jun 21, 1999
FLC COMPOSITE
K991491 · EBF
Harry J. Bosworth Co.
Dental · 54d
Cleared Jun 21, 1999
HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
K991513 · FPA
I-Flow Corp.
General Hospital · 52d
Cleared Jun 21, 1999
NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER...
K991742 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 31d
Cleared Jun 18, 1999
DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM...
K982096 · GXY
Rapid Mfg. Co.
Neurology · 368d
Cleared Jun 18, 1999
HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT...
K990250 · LBT
Morax
Chemistry · 143d
Cleared Jun 18, 1999
DIRECT HDL-CHOLESTEROL REAGENT
K990581 · LBS
Kamiya Biomedical Co.
Chemistry · 115d
Cleared Jun 18, 1999
RS-4V MUSCLE STIMULATOR
K990697 · IPF
Rs Medical
Physical Medicine · 107d
Cleared Jun 18, 1999
RENAL LINK
K990953 · KPF
Baxter Healthcare Corp
Gastroenterology & Urology · 88d
Cleared Jun 18, 1999
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
K990969 · IXW
Konica Medical Corp.
Radiology · 87d
Cleared Jun 18, 1999
GENYX MEDICAL INJECTION NEEDLE
K990996 · FBK
Genyx Medical, Inc.
Gastroenterology & Urology · 85d