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
110929–110952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 1993
WHITMORE ANKLE X-RAY EXTENSION (AXE)
K933778 · KPR
Whitmore Ent., Inc.
Radiology · 132d
Cleared Dec 13, 1993
ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES
K933812 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 131d
Cleared Dec 13, 1993
PULSE ELECTRIC TOOTHBRUSH
K933829 · JEQ
Dentatech Corp.
Dental · 130d
Cleared Dec 13, 1993
FASTFIL
K934184 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 108d
Cleared Dec 13, 1993
INTRASCAN(R) MINI-PACS
K934311 · IYO
Markcare Medical Systems, Inc.
Radiology · 103d
Cleared Dec 13, 1993
X-RAY ANGIOGRAPHIC SYSTEM
K934496 · IZI
Camtronics, Ltd.
Radiology · 89d
Cleared Dec 13, 1993
RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM
K934519 · IWE
Medtec, Inc.
Radiology · 87d
Cleared Dec 13, 1993
SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR
K934967 · IZO
Shimadzu Corp.
Radiology · 59d
Cleared Dec 13, 1993
MODEL ALPHA TS-2
K935004 · IYB
Dpa Consulting, Inc.
Radiology · 55d
Cleared Dec 13, 1993
RADIOGRAPHIC GENERATOR HFQ-WHIS
K935068 · IZO
Bennett X-Ray Corp.
Radiology · 49d
Cleared Dec 13, 1993
INSTA-FLO
K935209 · JAD
Medtec, Inc.
Radiology · 45d
Cleared Dec 10, 1993
MOTHERS TOUCH ONE HAND BREAST PUMP
K912355 · HGY
Hollister, Inc.
Obstetrics & Gynecology · 927d
Cleared Dec 10, 1993
STERI-OSS SCREW STYLE CP TITANIUM IMPLANT
K923695 · DZE
Steri-Oss, Inc.
Dental · 505d
Cleared Dec 10, 1993
STERI-OSS SCREW STYLE ITIANIUM IMPLANT
K924121 · DZE
Steri-Oss, Inc.
Dental · 483d
Cleared Dec 10, 1993
CVI-Q(TM) OPTION FOR P700
K924184 · IYO
Philips Medical Systems, Inc.
Radiology · 477d
Cleared Dec 10, 1993
MEDICAL DISPOSABLE BEDDING
K924420 · KNC
Hill-Rom, Inc.
Obstetrics & Gynecology · 465d
Cleared Dec 10, 1993
DUODERM HYDROCOLLOID GEL
K931618 · NAE
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 252d
Cleared Dec 10, 1993
NON-ABSORBABLE GAUZE
K931962 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 233d
Cleared Dec 10, 1993
SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)
K932676 · FRO
Polymedica Industries, Inc.
General & Plastic Surgery · 191d
Cleared Dec 10, 1993
HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
K932766 · LBR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 185d
Cleared Dec 10, 1993
ALMOST U, INC. BREAST PROSTHESIS
K933668 · KCZ
Almost U., Inc.
General & Plastic Surgery · 135d
Cleared Dec 10, 1993
SIGMA WASH CONCENTRATE SOLUTION
K933703 · JJE
Sigma Chemical Co.
Chemistry · 134d
Cleared Dec 10, 1993
DISPOSABLE PERFORATOR
K933894 · HBF
Codman & Shurtleff, Inc.
Neurology · 122d
Cleared Dec 10, 1993
DENTALON PLUS MODIFICATION
K934283 · EBG
Heraeus Kulzer, Inc.
Dental · 101d