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
85417–85440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1999
BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT
K990993 · JLW
Biocheck, Inc.
Chemistry · 90d
Cleared Jun 22, 1999
AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER
K990997 · IYE
Aktina Medical Physics Corp.
Radiology · 89d
Cleared Jun 22, 1999
VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO,...
K991005 · LLB
Dayspring Medical, Inc.
Gastroenterology & Urology · 89d
Cleared Jun 22, 1999
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM
K991056 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 84d
Cleared Jun 22, 1999
TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
K991146 · JLW
Biocheck, Inc.
Chemistry · 78d
Cleared Jun 22, 1999
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
K991191 · GAM
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 75d
Cleared Jun 22, 1999
BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150
K991199 · GXY
Biomed Products
Neurology · 75d
Cleared Jun 22, 1999
PRONTO DRY
K991248 · LYR
Medical Instruments Corporation Mic AG
Microbiology · 71d
Cleared Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BARBITURATES
K991440 · DIS
Roche Diagnostics Corp.
Toxicology · 57d
Cleared Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
K991443 · JXM
Roche Diagnostics Corp.
Toxicology · 57d
Cleared Jun 22, 1999
BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
K991637 · FTL
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 41d
Cleared Jun 22, 1999
MODIFICATION TO DIGIPAN
K991912 · EHD
Trophy Radiologie
Radiology · 15d
Cleared Jun 21, 1999
IMTEC BIOPIN
K982951 · DZL
Imtec Corp.
Dental · 301d
Cleared Jun 21, 1999
POWDER FREE VINYL EXAMINATION GLOVES
K983856 · LYZ
Shijiazhuang Brethern Plastic Co., Ltd.
General Hospital · 231d
Cleared Jun 21, 1999
POWDERED VINYL EXAMINATION GLOVE
K983893 · LYZ
Shijiazhuang Brethern Plastic Co., Ltd.
General Hospital · 231d
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