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

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175,820 results
129673–129696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 1989
TERUFUSION THREE WAY STOPCOCK
K891234 · FMG
Terumo Medical Corp.
General Hospital · 196d
Cleared Sep 19, 1989
PERRY* STERILE X-AM* GLOVES
K891444 · LYY
Smith & Nephew Medical
General Hospital · 188d
Cleared Sep 19, 1989
MITEK ANCHOR
K892126 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 173d
Cleared Sep 19, 1989
DISPOSABLE LATEX EXAMINATION GLOVES
K893767 · LYY
Masif Healthcare Products Sdn. Bhd.
General Hospital · 123d
Cleared Sep 19, 1989
RMI ARTERIAL PERFUSION CANNULA
K894243 · DQR
Research Medical, Inc.
Cardiovascular · 90d
Cleared Sep 19, 1989
PVS DUAL CURE VENEER BONDING KIT
K894391 · KLE
Jelenko Co.
Dental · 64d
Cleared Sep 19, 1989
MAXIMUM CURE SEALANT WITH FLUORIDE
K894566 · DYH
Reliance Orthodontic Products, Inc.
Dental · 60d
Cleared Sep 19, 1989
MARDX LYME DISEASE IFA (IGM) TEST SYSTEM
K894609 · LSR
Mardx, Inc.
Microbiology · 61d
Cleared Sep 19, 1989
30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES
K894801 · FMF
Advance Medical Designs, Inc.
General Hospital · 53d
Cleared Sep 19, 1989
VARIOUS DISPOSABLE SURGICAL GARMENTS
K895235 · FYE
Protect Corp. of Indiana, Inc.
General & Plastic Surgery · 43d
Cleared Sep 18, 1989
CATHETER INTRODUCER SHEATH
K890766 · DYB
Applied Vascular Devices, Inc.
Cardiovascular · 215d
Cleared Sep 18, 1989
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER
K891021 · DXE
Ideal Medical, Inc.
Cardiovascular · 202d
Cleared Sep 18, 1989
SRS-200 RADIOSURGERY SYSTEM
K891292 · IYE
Philips Medical Systems North...
Radiology · 192d
Cleared Sep 18, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892041 · LYY
United Gloves Sdn. Bhd.
General Hospital · 171d
Cleared Sep 18, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892466 · LYY
Zir Lih Industrial Co., Ltd.
General Hospital · 164d
Cleared Sep 18, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892610 · LYY
Pt. Indolex Karya Prakarsa
General Hospital · 161d
Cleared Sep 18, 1989
TUFFTEX PATIENT EXAM GLOVES
K892968 · LYY
Thai Latex, Inc.
General Hospital · 159d
Cleared Sep 18, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892970 · LYY
Naturub Sdn. Bhd.
General Hospital · 159d
Cleared Sep 18, 1989
CHILD SIZE - FILTER FLEX (TM)
K893030 · CAH
Life Design Systems, Inc.
General Hospital · 147d
Cleared Sep 18, 1989
LATEX EXAMINATION GLOVES
K893182 · LYY
Higlo Rubber Products Sdn. Bhd.
General Hospital · 154d
Cleared Sep 18, 1989
LATEX EXAMINATION GLOVES
K893449 · LYY
Lon Tai Chemical Industrial Co., Ltd.
General Hospital · 138d
Cleared Sep 18, 1989
AFTER LOADING DEVICE KIT
K893703 · IWJ
Medical Radiation Devices, Inc.
Radiology · 123d
Cleared Sep 18, 1989
VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000
K893716 · FPA
Baxter Healthcare Corp
General Hospital · 123d
Cleared Sep 18, 1989
PINK CASSETTE CADDIE
K893728 · IXA
Medical Technique Instruments, Inc.
Radiology · 124d