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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
130225–130248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893347 · LYY
Changzhou Foreign Economic Technical...
General Hospital · 84d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893352 · LYY
Hua Shu-Yee Industrial Co., Ltd.
General Hospital · 84d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893353 · LYY
Chorng Rong Industrial Co., Ltd.
General Hospital · 84d
Cleared Jul 14, 1989
VITATRACE
K893425 · DRX
Lectec Corp.
Cardiovascular · 73d
Cleared Jul 14, 1989
MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT
K893436 · DWS
Pioneering Technologies, Inc.
Cardiovascular · 72d
Cleared Jul 14, 1989
CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST)
K893466 · LKQ
Immuno Concepts, Inc.
Microbiology · 72d
Cleared Jul 14, 1989
CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)
K893467 · LIN
Immuno Concepts, Inc.
Microbiology · 72d
Cleared Jul 14, 1989
CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893468 · LIN
Immuno Concepts, Inc.
Microbiology · 72d
Cleared Jul 14, 1989
CRYSTAR(TM) ANTI-GREENING LIQUID
K893481 · ELL
Shofu Dental Corp.
Dental · 71d
Cleared Jul 14, 1989
BONDABLE RETAINER AND SPACE MAINTAINER
K893483 · EJF
American Orthodontics
Dental · 71d
Cleared Jul 14, 1989
MULTIPHASE ORTHODONTIC WIRE
K893484 · EJF
American Orthodontics
Dental · 71d
Cleared Jul 14, 1989
LAPAROSCOPIC SUCTION PROBE
K893527 · JOL
Dexide, Inc.
General Hospital · 67d
Cleared Jul 14, 1989
PLASTIC FORCE MODULE
K893550 · EJF
American Orthodontics
Dental · 67d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893551 · LYY
Mlb Holdings Sdn. Bhd.
General Hospital · 67d
Cleared Jul 14, 1989
X-RING AND SPEED STIX PLASTIC LIGATURES
K893555 · EJF
American Orthodontics
Dental · 67d
Cleared Jul 14, 1989
A.QC HCT LEVEL 1 AND 2
K893562 · GLK
Johnson & Johnson Professionals, Inc.
Hematology · 66d
Cleared Jul 14, 1989
ARGENCO 50 TYPE IV TYPE IV DENTAL GOLD ALLOY
K893566 · EJT
Argen Precious Metals, Inc.
Dental · 66d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893594 · LYY
Glovetex Industries
General Hospital · 66d
Cleared Jul 14, 1989
REMOVE ADHESIVE REMOVER
K893603 · KOX
Smith & Nephew United, Inc.
General & Plastic Surgery · 59d
Cleared Jul 14, 1989
BARD PLAQUE ELECTRODE ARRAY
K893611 · DRF
Bard Electrophysiology
Cardiovascular · 65d
Cleared Jul 14, 1989
MOBILE C-ARM
K893617 · OXO
Acoma Medical Imaging, Inc.
Radiology · 65d
Cleared Jul 14, 1989
MODIFIED ENDOGUIDE
K893642 · GEX
Luxar Corp.
General & Plastic Surgery · 60d
Cleared Jul 14, 1989
ELECTROSURGERY ANALYZER RF302
K893659 · GEI
Bio-Tek Instruments, Inc.
General & Plastic Surgery · 60d
Cleared Jul 14, 1989
VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
K893675 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 59d