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

Filters: Cleared only ×
175,820 results
130321–130344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1989
CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY
K894002 · LIN
Baxter Healthcare Corp
Microbiology · 66d
Cleared Aug 10, 1989
SHARPLAN CO2 LAPAROSCOPIC PROBE MODEL 792 TO 792BX
K894066 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 63d
Cleared Aug 10, 1989
SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS
K894210 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 52d
Cleared Aug 10, 1989
SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS
K894211 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 52d
Cleared Aug 10, 1989
MODIFIED PATIENT EXAMINATION GLOVES
K894311 · LYY
Safeskin Corp.
General Hospital · 27d
Cleared Aug 10, 1989
ZIMMER TENS
K894388 · GZJ
American Imex
Neurology · 24d
Cleared Aug 10, 1989
WELCON LIGHT HANDLE
K894397 · FTA
Welcon, Inc.
General & Plastic Surgery · 21d
Cleared Aug 10, 1989
AMMEL STERILE SURGEON'S GLOVES
K894501 · KGO
Mauricio Menconi
General Hospital · 22d
Cleared Aug 10, 1989
SCANLISA HUMAN CRP ELISA KIT
K894573 · DCK
Immuntech A/S
Immunology · 20d
Cleared Aug 10, 1989
TECHNICON DPA-1 SYSTEM RF METHOD
K894574 · DHR
Technicon Instruments Corp.
Immunology · 20d
Cleared Aug 10, 1989
GENERAL SURGICAL INSTRUMENTS
K894670 · DXC
Nopa Instruments
Cardiovascular · 69d
Cleared Aug 10, 1989
PENLON IDP PRESSURE FAILURE ALARM
K894689 · CAP
Penlon, Inc.
Anesthesiology · 17d
Cleared Aug 09, 1989
INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD
K885179 · DYB
Baxter Healthcare Corp
Cardiovascular · 238d
Cleared Aug 09, 1989
INTERMEDICS APR(TM) II FEMORAL COMPONENT
K890450 · JDJ
Intermedics Orthopedics
Orthopedic · 191d
Cleared Aug 09, 1989
USCI CORONARY INFUSION CATHETER
K891069 · DQY
C.R. Bard, Inc.
Cardiovascular · 161d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891114 · LYY
Ambusco Co., Inc.
General Hospital · 160d
Cleared Aug 09, 1989
SHIELDTEX PATIENT EXAMINATION GLOVE (LATEX)
K891263 · LYY
Dah Giap Rubber Industries Sdn Bhd
General Hospital · 154d
Cleared Aug 09, 1989
LATEX EXAMINATION GLOVES
K891445 · LYY
Superior Healthcare Group, Inc.
General Hospital · 147d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891499 · LYY
Promedica Sdn. Bhd.
General Hospital · 146d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVE
K891619 · LYY
Union Rubber Gloves Co., Ltd.
General Hospital · 145d
Cleared Aug 09, 1989
DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES
K891819 · LYY
Adler Industries, Inc.
General Hospital · 139d
Cleared Aug 09, 1989
INTRASITE* GEL (3) YEAR SHELF LIFE
K891870 · FRO
Smith & Nephew United, Inc.
General & Plastic Surgery · 152d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892136 · LYY
Beijing Light Industrial Products...
General Hospital · 127d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892148 · LYY
Setia Aircon Sdn. Bhd.
General Hospital · 121d