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
84697–84720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 1999
SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM
K992761 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Sep 01, 1999
CERALAS D10 810NM DIODE LASER
K992773 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 14d
Cleared Sep 01, 1999
A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE
K992808 · DXN
A&D Medical Div.
Cardiovascular · 12d
Cleared Sep 01, 1999
OPTIMAX/ COMPACT 2
K992818 · IXW
Protec GmbH & Co. KG
Radiology · 12d
Cleared Aug 31, 1999
CARD GUARD, MODEL CG-6550
K990478 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 196d
Cleared Aug 31, 1999
EQUINOX OCCLUSION BALLOON SYSTEM
K990487 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 196d
Cleared Aug 31, 1999
O.B. TAMPON
K990536 · HEB
Personal Products Co.
Obstetrics & Gynecology · 193d
Cleared Aug 31, 1999
LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50...
K991777 · LYY
Seltom Pacific Sdn. Bhd.
General Hospital · 98d
Cleared Aug 31, 1999
LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)
K991778 · LYY
Seltom Pacific Sdn. Bhd.
General Hospital · 98d
Cleared Aug 31, 1999
MODIFICATION OF JMS NEEDLES AND JMS SYRINGES
K991904 · FMI
Jms Co., Ltd.
General Hospital · 88d
Cleared Aug 31, 1999
LUMA LIGHT 2000 CURE LIGHT
K992102 · EBF
Lumalite, Inc.
Dental · 71d
Cleared Aug 31, 1999
MEDTRONIC AVE BRIDGE STENT
K992569 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 31, 1999
HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
K992636 · DXJ
Hewlett-Packard Co.
Cardiovascular · 25d
Cleared Aug 30, 1999
ENDOSONICS TRAK BACK DEVICE
K990271 · DQX
Endosonics Corp.
Cardiovascular · 214d
Cleared Aug 30, 1999
CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
K990310 · CAK
Charter Medical, Ltd.
General Hospital · 210d
Cleared Aug 30, 1999
JMS A. V. FISTULA NEEDLE SET
K990470 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 195d
Cleared Aug 30, 1999
JMS APHERESIS NEEDLE
K990510 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 193d
Cleared Aug 30, 1999
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
K991237 · MUJ
Radionics, Inc.
Radiology · 140d
Cleared Aug 30, 1999
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
K991437 · FRN
Wells Johnson Co.
General Hospital · 126d
Cleared Aug 30, 1999
RENACLEAR DIALYZER CLEANING SYSTEM
K991851 · LIF
Minntech Corp.
Gastroenterology & Urology · 90d
Cleared Aug 30, 1999
PASCO MIC AND MIC/ID PANELS
K992059 · JWY
Pasco Laboratories, Inc.
Microbiology · 73d
Cleared Aug 30, 1999
REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM
K992066 · KPR
GE Medical Systems
Radiology · 73d
Cleared Aug 30, 1999
PASCO MIC AND MIC/ID PANELS (CEFUROXIME)
K992076 · JTN
Pasco Laboratories, Inc.
Microbiology · 70d
Cleared Aug 30, 1999
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH...
K992162 · LZC
Safeskin Corp.
General Hospital · 66d