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
86617–86640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 1999
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD)
K990127 · KNT
Corpak Medsystems
Gastroenterology & Urology · 28d
Cleared Feb 10, 1999
SUPRASHIELD EXPRESS STERILIZATION WRAP
K990300 · FRG
Allegiance Healthcare Corp.
General Hospital · 9d
Cleared Feb 09, 1999
RE NU
K973289 · EJR
Pacific Rim Dental, Inc.
Dental · 525d
Cleared Feb 09, 1999
TCM 3000 AND TCM ENDO
K981679 · EFB
NOUVAG AG
Dental · 272d
Cleared Feb 09, 1999
RESIN 4
K981862 · EBI
Harry J. Bosworth Co.
Dental · 280d
Cleared Feb 09, 1999
STERITITE PROCESS INDICATOR ACCESSORIES
K982151 · JOJ
Case Medical, Inc.
General Hospital · 236d
Cleared Feb 09, 1999
1ST IMPRESSION
K983106 · ELW
Den-Mat Corp.
Dental · 158d
Cleared Feb 09, 1999
COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105,...
K983411 · FPA
Valnet Medical Corp.
General Hospital · 134d
Cleared Feb 09, 1999
LITE-TOUCH SYRINGE
K983430 · FMF
Medicore, Inc.
General Hospital · 133d
Cleared Feb 09, 1999
PARAGON BASAL/BOLUS ADMINISTRATION SET
K984063 · FPA
I-Flow Corp.
General Hospital · 85d
Cleared Feb 09, 1999
DC-CORE
K984097 · EBF
S & C Polymer GmbH
Dental · 84d
Cleared Feb 09, 1999
SYS STIM 294, MODEL ME 294
K984114 · IPF
Mettler Electronics Corp.
Physical Medicine · 84d
Cleared Feb 09, 1999
POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
K984125 · LYY
Kilang Barangan Getah Dioh
General Hospital · 83d
Cleared Feb 09, 1999
ENIGMA DENTURE TEETH
K984128 · ELM
Davis Schottlander & Davis, Ltd.
Dental · 83d
Cleared Feb 09, 1999
SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER...
K984142 · IPF
Mettler Electronics Corp.
Physical Medicine · 83d
Cleared Feb 09, 1999
SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID
K984144 · JWY
Ab Biodisk
Microbiology · 83d
Cleared Feb 09, 1999
PARAGON INFUSION
K984146 · FPA
I-Flow Corp.
General Hospital · 82d
Cleared Feb 09, 1999
NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE
K984311 · LZA
Sumirubber Industries (Kedah) Sdn. Bhd.
General Hospital · 69d
Cleared Feb 09, 1999
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K984460 · LYZ
Shanghai Huamao Gloves Co., Ltd.
General Hospital · 55d
Cleared Feb 09, 1999
PRE-POWDER VINYL PATIENT EXAMINATION GLOVES
K984461 · LYZ
Shanghai Huamao Gloves Co., Ltd.
General Hospital · 55d
Cleared Feb 09, 1999
SCICAN CLASSIC
K984556 · EIA
Scholly Fiberoptic GmbH
Dental · 48d
Cleared Feb 09, 1999
ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL...
K984609 · EIA
Lite Specialty Metal Works, Inc.
Dental · 43d
Cleared Feb 09, 1999
POWDER FREE NITRILE EXAMINATION GLOVES
K984610 · LZA
Shiva Medicare , Ltd.
General Hospital · 42d
Cleared Feb 09, 1999
PARAGON BOLUS ACCESSORY SET
K984638 · FPA
I-Flow Corp.
General Hospital · 40d