FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,281 results for "health"
3073–3096 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 10, 2003
IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
K031059 · MHJ
Ivd Research, Inc.
Microbiology · 104d
Cleared Jul 07, 2003
RESPIRATORY HUMIDIFIER, MODEL MR850
K020332 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 522d
Cleared Jul 01, 2003
HL888RA
K031835 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Jul 01, 2003
HL168R
K031695 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Jun 30, 2003
APEX ELECTRIC HANDPIECE SYSTEM
K031540 · EKX
Lares Research, Inc.
Dental · 45d
Cleared Jun 25, 2003
LIPOPROTEIN CALIBRATOR
K031682 · JIX
Bayer Healthcare, LLC
Chemistry · 26d
Cleared Jun 25, 2003
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
K031644 · JJY
Bayer Healthcare, LLC
Chemistry · 29d
Cleared Jun 24, 2003
BAYER ADVIA CENTAUR CA 19-9 ASSAY
K031393 · NIG
Bayer Healthcare, LLC
Immunology · 53d
Cleared Jun 23, 2003
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
K031038 · NBC
Bayer Healthcare, LLC
Chemistry · 83d
Cleared Jun 20, 2003
TEMPORARY TITANIUM ANEURYSM CLIP
K031468 · HCH
Cardinalhealth
Neurology · 42d
Cleared Jun 19, 2003
SOLUTION FACE MASKS
K031353 · FXX
A Plus International, Inc.
General Hospital · 51d
Cleared Jun 17, 2003
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
K030099 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 158d
Cleared Jun 12, 2003
SINGLE USE ORAL MASK, MODEL HC455A
K023670 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 224d
Cleared Jun 12, 2003
FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
K023559 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 232d
Cleared Jun 11, 2003
NANO-TICROWN
K031627 · EJH
Nano-Write Corp.
Dental · 15d
Cleared Jun 11, 2003
EKGCARD SYSTEM
K030535 · DPS
Qrs Diagnostic, LLC
Cardiovascular · 111d
Cleared Jun 11, 2003
DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
K024010 · EZL
The Kendall Company Div. of Tyco...
Gastroenterology & Urology · 189d
Cleared Jun 10, 2003
KLINIDRAPE SURGICAL DRAPES
K031131 · KKX
Molnlycke Health Care
General Hospital · 62d
Cleared Jun 05, 2003
PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US
K031470 · BZD
Tyco Healthcare Nancy
Anesthesiology · 27d
Cleared May 30, 2003
EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP
K030587 · DRN
S-Tct Health, Inc.
Cardiovascular · 94d
Cleared May 20, 2003
BODY CLOCK TENS N' TONE
K022849 · GZJ
Body Clock Health Care, Ltd.
Neurology · 266d
Cleared May 02, 2003
HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945...
K030349 · MNW
Bonso Electronics International, Inc.
Gastroenterology & Urology · 88d
Cleared May 02, 2003
NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
K030207 · LZA
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 101d
Cleared May 02, 2003
AIRLIFE DEMAND NASAL CANNULA
K023673 · NFB
Allegiance Healthcare Corp.
Anesthesiology · 182d