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
102409–102432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 1995
DEGULOR S
K951788 · EJT
Degussa Corp.
Dental · 56d
Cleared Jun 12, 1995
PONTALLOR 3
K951790 · EJT
Degussa Corp.
Dental · 56d
Cleared Jun 12, 1995
DEPALOR
K951791 · EJT
Degussa Corp.
Dental · 56d
Cleared Jun 12, 1995
BIODERM MEDICAL TRANSPARENT FILM DRESSING
K951842 · MGP
Bioderm, Inc.
General & Plastic Surgery · 53d
Cleared Jun 12, 1995
HUMID-VENT FILTER PEDI
K952084 · BYD
Gibeck, Inc.
Anesthesiology · 40d
Cleared Jun 12, 1995
ASLAN LAPRETRACT
K952264 · GCJ
Aslan Medical Technologies, Ltd.
General & Plastic Surgery · 28d
Cleared Jun 12, 1995
SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE
K952266 · BSR
Stebar Instrument Corp.
Anesthesiology · 28d
Cleared Jun 12, 1995
MEGABEAM ASPIRATING ENDOCULAR PROBE
K952340 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 24d
Cleared Jun 09, 1995
CORPAK GASTROSTOMY TUBE
K931921 · KNT
Corpak Co.
Gastroenterology & Urology · 784d
Cleared Jun 09, 1995
PENT NOVA AUTOBLOCK SYRINGE
K933569 · MEG
Medi-Hut Co., Inc.
General Hospital · 687d
Cleared Jun 09, 1995
MEDICAL LINEAR ACCELERATOR
K935615 · IYE
Accelerator Systems Intl., Inc.
Radiology · 564d
Cleared Jun 09, 1995
ABBOTT VISION GLYCATED HB, MODIFICATION
K936285 · LCP
Abbott Laboratories
Hematology · 526d
Cleared Jun 09, 1995
ABBOTT PROJECT I, SPECTRUM
K945566 · JJE
Abbott Laboratories
Chemistry · 231d
Cleared Jun 09, 1995
Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05
K945800 · JQB
Diagnostic Chemicals , Ltd.
Chemistry · 193d
Cleared Jun 09, 1995
SYSMEX(TM) F-820, 520
K945837 · GKZ
Sysmex Corp.
Hematology · 192d
Cleared Jun 09, 1995
KARL STORZ KNIVES, CURETTS, HOOKS, PROBES
K945891 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 190d
Cleared Jun 09, 1995
EMERGENCY RESPONSE SAFETY KIT
K946001 · FXX
Ani Safety, Inc.
General Hospital · 200d
Cleared Jun 09, 1995
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
K946158 · LLM
Incstar Corp.
Microbiology · 183d
Cleared Jun 09, 1995
DIGITEST
K950237 · EAT
Parkell, Inc.
Dental · 140d
Cleared Jun 09, 1995
BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING
K950685 · KMF
Bioderm, Inc.
General & Plastic Surgery · 115d
Cleared Jun 09, 1995
SAS SALMONELLA H B ANTISERUM
K951069 · GRM
Sa Scientific, Inc.
Microbiology · 93d
Cleared Jun 09, 1995
OBSTI-HOOK
K951148 · HGE
Onli
Obstetrics & Gynecology · 88d
Cleared Jun 09, 1995
VIDAMED 50 ELECTROSURGICAL GENERATOR, VIDAMED AEC (ADJUSTABLE ELECTROSURGICAL...
K951245 · GEI
Vidamed, Inc.
General & Plastic Surgery · 84d
Cleared Jun 09, 1995
IL TEST DIGOXIN, PN 181761-00
K951391 · KXT
Instrumentation Laboratory CO
Toxicology · 74d