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
103513–103536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1995
URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950136 · DJG
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 82d
Cleared Apr 05, 1995
ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE
K950156 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 78d
Cleared Apr 05, 1995
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
K950181 · LDJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 78d
Cleared Apr 05, 1995
KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA
K950282 · KOC
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 71d
Cleared Apr 05, 1995
OCTEIA IGF-1 KIT
K950510 · CFL
Immunodiagnostic Systems , Ltd.
Chemistry · 58d
Cleared Apr 05, 1995
SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER
K950731 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 48d
Cleared Apr 05, 1995
ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR)
K950903 · IOR
Orthofab, Inc.
Physical Medicine · 36d
Cleared Apr 05, 1995
ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)
K950904 · IOR
Orthofab, Inc.
Physical Medicine · 36d
Cleared Apr 05, 1995
AVON MASSAGING HAIRBRUSH
K950931 · ISA
Siegel,Mandell & Davidson,P.C.
Physical Medicine · 35d
Cleared Apr 05, 1995
NOVATRANS II
K951129 · DRS
Medex, Inc.
Cardiovascular · 23d
Cleared Apr 04, 1995
BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER
K942250 · JJQ
Biowhittaker Molecular Applications,...
Microbiology · 330d
Cleared Apr 04, 1995
WHITSOFT
K942361 · JJQ
Biowhittaker Molecular Applications,...
Microbiology · 322d
Cleared Apr 04, 1995
CARRYALL ENHANCEMENTS
K943931 · DXH
Instromedix, Inc.
Cardiovascular · 235d
Cleared Apr 04, 1995
ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
K944092 · JEC
Orthofix Srl
Orthopedic · 225d
Cleared Apr 04, 1995
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS
K945911 · JTZ
Bioclinical Systems, Inc.
Microbiology · 123d
Cleared Apr 04, 1995
POLYDERM
K950033 · LZA
Wilshire Technologies
General Hospital · 90d
Cleared Apr 04, 1995
LE CLEAN MACHINE
K950240 · ELC
Parkell, Inc.
Dental · 74d
Cleared Apr 04, 1995
TURBO 25/30
K950256 · ELC
Parkell, Inc.
Dental · 71d
Cleared Apr 04, 1995
AUTOLASER MULTI FORMAT CAMERA
K950288 · LMC
Afp Imaging Corp.
Radiology · 69d
Cleared Apr 04, 1995
WELCH ALLYN OPHTHALMOSCOPE
K950461 · HLI
Welch Allyn, Inc.
Ophthalmic · 60d
Cleared Apr 04, 1995
B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE
K950982 · FCG
B. Braun of America, Inc.
Gastroenterology & Urology · 32d
Cleared Apr 04, 1995
RAINS FRONTAL SINUS STENT
K951066 · KAM
Smith & Nephew Richards, Inc.
General & Plastic Surgery · 27d
Cleared Apr 04, 1995
SUNGLASSES
K951209 · HQY
Mainland Wholesale
Ophthalmic · 18d
Cleared Apr 03, 1995
BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE
K942245 · JJQ
Biowhittaker Molecular Applications,...
Microbiology · 329d