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
107329–107352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1994
THERMOSCAN INSTANT THERMOMETER IR-5000
K930680 · FLL
Thermoscan, Inc.
General Hospital · 525d
Cleared Jul 20, 1994
CORDIS GRAVITY COMPENSATING ACCESSORY
K932429 · JXG
Cordis Corp.
Neurology · 426d
Cleared Jul 20, 1994
COSMET
K933465 · KCZ
Great Bay Medical Products, Inc.
General & Plastic Surgery · 369d
Cleared Jul 20, 1994
STIMULATING SURGICAL INSTRUMENTS
K934733 · ETN
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 292d
Cleared Jul 20, 1994
OPUS PROCAINAMIDE TEST SYSTEM
K934762 · LAR
Pb Diagnostic Systems, Inc.
Toxicology · 289d
Cleared Jul 20, 1994
HYDROTORQUE GUIDE WIRE
K935232 · DQX
Kingston Technologies, Inc.
Cardiovascular · 261d
Cleared Jul 20, 1994
WALLACH LEEP PROCEDURE KIT
K935634 · HGI
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 239d
Cleared Jul 20, 1994
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
K935984 · JQB
Sigma Diagnostics, Inc.
Chemistry · 218d
Cleared Jul 20, 1994
CMS-90 BLOOD PRESSURE MEASUREMENT ASSISTANT
K936313 · DXQ
Prevention Sciences
Cardiovascular · 285d
Cleared Jul 20, 1994
DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4
K940433 · DIF
Medical Analysis Systems, Inc.
Toxicology · 170d
Cleared Jul 20, 1994
DNA TRIGLYCERIDE PROCEDURE
K941063 · JGY
Data Medical Associates, Inc.
Chemistry · 134d
Cleared Jul 20, 1994
ACS CARDIO-TROL CONTROL
K941115 · JJY
Analytical Control Systems, Inc.
Chemistry · 135d
Cleared Jul 20, 1994
DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE
K941221 · CGJ
Dupont Medical Products
Chemistry · 128d
Cleared Jul 20, 1994
STANBIO ALT/GPT (LUQUI-UV) TEST SET
K941314 · CKA
Stanbio Laboratory
Chemistry · 124d
Cleared Jul 20, 1994
PHANTOM
K941363 · IZL
Dynarad Corp.
Radiology · 121d
Cleared Jul 20, 1994
CEDIA DAU AMPHETAMINES ASSAY
K941372 · DKZ
Microgenics Corp.
Toxicology · 120d
Cleared Jul 20, 1994
CRONEX REGULAR CASSETTE
K941475 · IXA
Dupont Medical Products
Radiology · 114d
Cleared Jul 20, 1994
KIT PAK DRESSING CHANGE TRAY
K941499 · KGX
Kit Pak, Inc.
General Hospital · 113d
Cleared Jul 20, 1994
GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT
K941662 · EQH
Gm Engineering, Inc.
Ear, Nose, Throat · 106d
Cleared Jul 20, 1994
BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550
K941921 · DWA
Medtronic Bio-Medicus, Inc.
Cardiovascular · 91d
Cleared Jul 20, 1994
DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)
K942264 · JAA
Eigen Video
Radiology · 72d
Cleared Jul 20, 1994
TECNADYNE T-CUFF
K942303 · KCY
Technadyne Scientific, Inc.
General & Plastic Surgery · 68d
Cleared Jul 20, 1994
UNICATH FAMILY
K942503 · IZI
Angiographic Devices Corp.
Radiology · 55d
Cleared Jul 20, 1994
POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
K942774 · MGP
The Kendal Co.
General & Plastic Surgery · 37d