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
84793–84816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1999
QS DELIVERY SYSTEM
K991254 · KYZ
Sub-Q, Inc.
General Hospital · 132d
Cleared Aug 23, 1999
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
K991559 · FXX
Medline Industries, Inc.
General Hospital · 111d
Cleared Aug 23, 1999
MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA
K991896 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 81d
Cleared Aug 23, 1999
MRGP OPTICAL TRACKING UNIT
K991943 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 75d
Cleared Aug 23, 1999
PARSET, MODEL A10001E
K992104 · FPA
Rd Medical Mfg., Inc.
General Hospital · 62d
Cleared Aug 23, 1999
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES
K992107 · LYZ
General Gloves Corp.
General Hospital · 62d
Cleared Aug 23, 1999
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
K992123 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 61d
Cleared Aug 23, 1999
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE
K992299 · LZA
Pamitex Industries Sdn Bhd
General Hospital · 46d
Cleared Aug 23, 1999
ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM
K992470 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 28d
Cleared Aug 23, 1999
SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
K992644 · MUH
Sirona Dental Systems GmbH
Radiology · 17d
Cleared Aug 20, 1999
MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V....
K990236 · FOZ
Johnson & Johnson Medical, Div. of...
General Hospital · 207d
Cleared Aug 20, 1999
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
K991083 · CHH
Otsuka Pharmaceutical Co., Ltd.
Chemistry · 142d
Cleared Aug 20, 1999
SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING
K991312 · MDA
Library Medical, Inc.
General & Plastic Surgery · 126d
Cleared Aug 20, 1999
JOBST READY-TO-WEAR ARM SLEEVES
K991570 · DWL
Beiersdorf-Jobt, Inc.
General Hospital · 107d
Cleared Aug 20, 1999
CAPSULAR SHRINKAGE ELECTRODE
K991830 · JOS
Linvatec Corp.
General & Plastic Surgery · 84d
Cleared Aug 20, 1999
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
K991909 · EBC
Dentsply Intl.
Dental · 74d
Cleared Aug 20, 1999
INTRAVASCULAR ADMINISTRATION SET
K991932 · FPA
The Kipp Group
General Hospital · 73d
Cleared Aug 20, 1999
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
K991985 · FPA
Cook, Inc.
General Hospital · 67d
Cleared Aug 20, 1999
CHOLESITE TEST SYSTEM
K992132 · CHH
Gds Technology, LLC
Chemistry · 58d
Cleared Aug 20, 1999
LACTOSORB SHEETS
K992158 · JEY
Biomet, Inc.
Dental · 56d
Cleared Aug 20, 1999
PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1
K992361 · FYD
Pall Medical
General Hospital · 36d
Cleared Aug 20, 1999
ADVANTA GRAFT
K992441 · DYF
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Aug 20, 1999
ADVANTA GRAFT
K992443 · DSY
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Aug 20, 1999
BLULAZE
K992620 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 15d