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
90577–90600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1998
KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES
K972488 · HET
Karl Storz Endoscopy
Obstetrics & Gynecology · 204d
Cleared Jan 22, 1998
GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90
K972576 · LQL
Accumed Intl., Inc.
Microbiology · 196d
Cleared Jan 22, 1998
MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM...
K972669 · CGA
Polymer Technology Systems, Inc.
Chemistry · 190d
Cleared Jan 22, 1998
ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION),...
K972889 · EBW
W & H Dentalwerk
Dental · 170d
Cleared Jan 22, 1998
IBU, INTEGRATED BRACHY THERAPY UNIT
K973848 · KPQ
Nucletron Corp.
Radiology · 106d
Cleared Jan 22, 1998
GENERAL PURPOSE ATL NEEDLE GUIDE KIT
K973958 · ITX
Protek Medical Products, Inc.
Radiology · 98d
Cleared Jan 22, 1998
BECTON DICKINSON TWINPAK
K974006 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 93d
Cleared Jan 22, 1998
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD
K974044 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Jan 22, 1998
RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS
K974066 · GEI
Microline Pentax, Inc.
General & Plastic Surgery · 87d
Cleared Jan 22, 1998
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
K974076 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 85d
Cleared Jan 22, 1998
FORMULA FOR ARCHIMED
K974079 · DPS
Biosound Esaote, Inc.
Cardiovascular · 85d
Cleared Jan 22, 1998
ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA
K974122 · MQX
Scientific Health Care
General Hospital · 83d
Cleared Jan 22, 1998
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS...
K974155 · DTN
Baxter Healthcare Corp
Cardiovascular · 79d
Cleared Jan 22, 1998
PHILIPS EASYVISION WORKSTATION
K974207 · LLZ
Philips Medical Systems North...
Radiology · 73d
Cleared Jan 22, 1998
MIGHTY AIR
K974319 · FNM
Wheelchairs of Kansas
General Hospital · 66d
Cleared Jan 22, 1998
MILLS INCUS HA SLEEVE
K974365 · ETB
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 64d
Cleared Jan 22, 1998
PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW...
K974471 · LJT
Sims Deltec, Inc.
General Hospital · 57d
Cleared Jan 22, 1998
REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
K974699 · DKB
Consolidated Technologies, Inc.
Toxicology · 37d
Cleared Jan 22, 1998
AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL
K974822 · JJY
Avl Scientific Corp.
Chemistry · 29d
Cleared Jan 22, 1998
BM PRECIPATH(R) HDL/LDL-C CONTROL
K974826 · JJY
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Jan 22, 1998
SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST
K974851 · JHI
San Diego Biotech
Chemistry · 24d
Cleared Jan 22, 1998
LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
K974859 · CFJ
Diagnostic Chemicals , Ltd.
Chemistry · 24d
Cleared Jan 21, 1998
DEPUY AMK 3 PEG PATELLA
K972643 · JWH
Depuy, Inc.
Orthopedic · 190d
Cleared Jan 21, 1998
QUEST PET IMAGING SYSTEM
K973396 · KPS
Ugm Medical Systems, Inc.
Radiology · 149d