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
104497–104520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1995
LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC CONTACT LENS
K950283 · LPL
Permeable Technologies, Inc.
Ophthalmic · 14d
Cleared Feb 06, 1995
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM
K931286 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 696d
Cleared Feb 06, 1995
POSTERIOR STABILIZED APOLLO KNEE SYSTEM
K935789 · JWH
Intermedics Orthopedics
Orthopedic · 427d
Cleared Feb 06, 1995
UNIVERSAL WRIST
K940297 · JWI
Turnkey Intergration USA, Inc.
Orthopedic · 381d
Cleared Feb 06, 1995
SEDRATROL
K940430 · GJR
Medical Specialties Intl., Inc.
Hematology · 371d
Cleared Feb 06, 1995
CERES 900C & CERES UV900C
K942923 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 230d
Cleared Feb 06, 1995
VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM
K945458 · GIM
Bd Becton Dickinson Vacutainer...
Chemistry · 91d
Cleared Feb 06, 1995
BIODERM MEDICAL COMPOSITE WOUND DRESSING
K946292 · MGP
Bioderm, Inc.
General & Plastic Surgery · 41d
Cleared Feb 06, 1995
KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR
K946330 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 39d
Cleared Feb 06, 1995
ABDOMINAL WALL RETRACTOR
K950214 · GCJ
Omni-Tract Surgical, Div. Minn....
General & Plastic Surgery · 18d
Cleared Feb 03, 1995
IMAGE TRANSPORT SERIES II
K925963 · LLZ
Dataview Imaging Intl., Inc.
Radiology · 800d
Cleared Feb 03, 1995
IMAGE TRANSPORT SERIES III
K925964 · LMD
Dataview Imaging Intl., Inc.
Radiology · 800d
Cleared Feb 03, 1995
MULTI-DOP L
K930458 · IYN
Dantec Medical, Inc.
Radiology · 736d
Cleared Feb 03, 1995
GERONIMO
K935750 · ITI
Redman, Inc.
Physical Medicine · 434d
Cleared Feb 03, 1995
GERONIMO PR
K935751 · ITI
Redman, Inc.
Physical Medicine · 434d
Cleared Feb 03, 1995
MASTERSCREEN BODY
K936108 · JEH
Erich Jaeger GmbH & Co. KG
Anesthesiology · 403d
Cleared Feb 03, 1995
IV BAG PUMP
K940657 · FPA
I-Flow Corp.
General Hospital · 353d
Cleared Feb 03, 1995
RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT
K940851 · ITI
Redman, Inc.
Physical Medicine · 345d
Cleared Feb 03, 1995
CHIEF STANDUP WHEELCHAIR
K940852 · IPL
Redman, Inc.
Physical Medicine · 345d
Cleared Feb 03, 1995
CHIEF SR
K940919 · IPL
Redman, Inc.
Physical Medicine · 344d
Cleared Feb 03, 1995
ROAD SAVAGE
K940920 · ITI
Redman, Inc.
Physical Medicine · 343d
Cleared Feb 03, 1995
GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
K941459 · JWY
Baxter Diagnostics, Inc.
Microbiology · 316d
Cleared Feb 03, 1995
DISPOSABLE CUTANEOUS ELECTRODES
K941799 · GXY
Bio-Logic Systems Corp.
Neurology · 297d
Cleared Feb 03, 1995
VARIOUS ELECTRODES
K941928 · GWN
Bio-Logic Systems Corp.
Neurology · 289d