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

5,280 results for "health"
2209–2232 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 08, 2011
PAINFUSOR CATHETER
K111031 · BSO
Plan 1 Health, S.R.L.
Anesthesiology · 85d
Cleared Jul 07, 2011
ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH...
K103714 · KGO
Ansell Healthcare Products, LLC
General Hospital · 198d
Cleared Jul 01, 2011
WELL-LIFE OTC EMS SYSTEM
K102786 · NGX
Well-Life Healthcare Limited
Physical Medicine · 277d
Cleared Jun 24, 2011
IMPAX VOLUME VIEWING
K111638 · LLZ
Agfa Healthcare N.V.
Radiology · 11d
Cleared Jun 22, 2011
MICROSCAN MICROSTEP
K111394 · LTT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 35d
Cleared Jun 14, 2011
ADDITIVE CAP
K111217 · KPE
Baxter Healthcare Corp
General Hospital · 43d
Cleared Jun 14, 2011
SPACELABS PATHFINDER SL HOLTER ANALYZER
K110001 · DQK
Spacelabs Healthcare, Ltd.
Cardiovascular · 162d
Cleared Jun 10, 2011
NAVIGATOR APPLICATIONS SUITE
K102389 · BSZ
GE Healthcare Finland Oy
Anesthesiology · 291d
Cleared Jun 08, 2011
STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH...
K110272 · KGO
Cardinal Health, Inc.
General Hospital · 128d
Cleared Jun 03, 2011
DISCOVERY NM 630
K111445 · KPS
Ge Healthcare
Radiology · 10d
Cleared Jun 02, 2011
ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
K103548 · JIT
Siemens Healthcare Diagnostics, Inc.
Immunology · 181d
Cleared May 16, 2011
STRATUS CS ACUTE CARE D-DIMER
K110303 · DAP
Siemens Healthcare Diagnostics
Hematology · 104d
Cleared May 16, 2011
CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
K101779 · KPR
Jpi Healthcare Co, Ltd.
Radiology · 325d
Cleared May 13, 2011
HEALTH CARE SYSTEM SOFTWARE
K110948 · NBW
Taidoc Technology Corporation
Chemistry · 39d
Cleared May 13, 2011
DIMENSIONS HB1C KIT, MODEL DF105A
K102510 · LCP
Siemens Healthcare Diagnostics
Chemistry · 259d
Cleared May 06, 2011
STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
K111015 · KGO
Cardinal Health, Inc.
General Hospital · 25d
Cleared May 05, 2011
CENTRICITY PACS
K110875 · LLZ
Ge Healthcare
Radiology · 36d
Cleared May 04, 2011
ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
K102681 · LGD
Siemens Healthcare Diagnostics, Inc.
Microbiology · 229d
Cleared May 03, 2011
READY VIEW
K110573 · LLZ
Ge Healthcare (Ge Medical Systems Scs)
Radiology · 63d
Cleared Apr 28, 2011
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
K103683 · JJX
Siemens Healthcare Diagnostics
Chemistry · 132d
Cleared Apr 26, 2011
AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
K110834 · LLZ
Ge Healthcare
Radiology · 32d
Cleared Apr 21, 2011
SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
K103770 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 115d
Cleared Apr 19, 2011
SPACELABS SMART DISCLOSURE SYSTEM
K110779 · DQK
Spacelabs Healthcare
Cardiovascular · 29d
Cleared Apr 19, 2011
3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR
K103277 · FRC
3M Company-3M Health Care
General Hospital · 165d