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
107233–107256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1994
RH-806/GS MODEL TRANSQ(R)2
K932620 · EGJ
Iomed, Inc.
Physical Medicine · 420d
Cleared Jul 26, 1994
RH-801/GS MODEL TRANSQ(R)1
K932621 · EGJ
Iomed, Inc.
Physical Medicine · 420d
Cleared Jul 26, 1994
GROUND PLATE ELECTRODE
K933807 · GXY
Cadwell Laboratories, Inc.
Neurology · 356d
Cleared Jul 26, 1994
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
K934292 · DTZ
Minntech Corp.
Cardiovascular · 327d
Cleared Jul 26, 1994
PHORESOR II AUTO, MODEL PM800 MODIFICATION
K934335 · EGJ
Iomed, Inc.
Physical Medicine · 322d
Cleared Jul 26, 1994
HP M177XA CARDIOGRAPHS
K935772 · LOS
Hewlett-Packard Co.
Cardiovascular · 235d
Cleared Jul 26, 1994
THERAPLAN V05B/ TP-11 V09B
K940237 · IYE
Theratronics, Inc.
Radiology · 189d
Cleared Jul 26, 1994
SPONGE, LAPAROTOMY, VARIOUS SIZE
K940436 · GDY
Shawnee Products, Inc.
General & Plastic Surgery · 176d
Cleared Jul 26, 1994
CLEARVIEW UTERINE MANIPULATOR
K940681 · LKF
Clinical Innovations, Inc.
Obstetrics & Gynecology · 166d
Cleared Jul 26, 1994
ASEP(TM) PLUS SURGICAL GOWN
K940931 · FYA
Angelica Uniform Group, Inc.
General Hospital · 148d
Cleared Jul 26, 1994
DENTAL TRAY
K941349 · EIA
Cush Medical Products
Dental · 127d
Cleared Jul 26, 1994
SARNS FILTERED VENOUS RESERVIOR MODIFICATION
K941654 · DTP
3M Health Care, Sarns
Cardiovascular · 112d
Cleared Jul 26, 1994
NCE REPLACEMENT BATTERIES
K941995 · LDD
National Custom Ent., Inc.
Cardiovascular · 92d
Cleared Jul 26, 1994
PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM
K942024 · LJT
Pharmacia Deltec, Inc.
General Hospital · 91d
Cleared Jul 26, 1994
L-CATH CATHETER SYSTEM - PORT L-CATH
K942103 · LJT
Luther Medical Products, Inc.
General Hospital · 85d
Cleared Jul 26, 1994
VIAL VENT FILTER
K942275 · FPB
Gelman Sciences, Inc.
General Hospital · 77d
Cleared Jul 26, 1994
SURGICAL TIP CLEANER
K942577 · GEI
White Knight Healthcare
General & Plastic Surgery · 56d
Cleared Jul 26, 1994
BODY FLEX
K942950 · ISA
Conair Corp.
Physical Medicine · 33d
Cleared Jul 26, 1994
CURAFIL WOUND GEL DRESSING
K943073 · MGQ
Kendall Healthcare Products Co....
General & Plastic Surgery · 28d
Cleared Jul 26, 1994
BIOPLAR FORCEPS
K943231 · GEI
Cook Urological, Inc.
General & Plastic Surgery · 20d
Cleared Jul 25, 1994
INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM.
K922872 · DZE
Interpore Intl.
Dental · 770d
Cleared Jul 25, 1994
AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR
K930867 · LKF
United States Surgical, A Division of...
Obstetrics & Gynecology · 521d
Cleared Jul 25, 1994
OPTICOM M600
K932258 · HPT
Clement Clarke, Inc.
Ophthalmic · 441d
Cleared Jul 25, 1994
MARS SUNGLASSES
K932484 · HQY
Mars Promotional Services, Inc.
Ophthalmic · 427d