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
101497–101520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 1995
BSC/CA 30 & 40 SENSATION, MODELS 930 & 940
K952221 · DSP
Boston Scientific Corp
Cardiovascular · 91d
Cleared Aug 11, 1995
XENON GAS BREATHING CIRCUIT
K952223 · IYT
Intertech Resources, Inc.
Radiology · 91d
Cleared Aug 11, 1995
C-FLEX SEPTAL SPLINTS
K952226 · LYA
Trebay Medical Corp.
Ear, Nose, Throat · 91d
Cleared Aug 11, 1995
MODEL DELTA, OM OXYGEN CONCENTRATOR
K952268 · CAW
Caire, Inc.
Anesthesiology · 88d
Cleared Aug 11, 1995
ROYAL SHIELD PINK & BLUE COLORED NON-STERILE LATEX EXAMINATION GLOVES
K952589 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 67d
Cleared Aug 11, 1995
ROYAL SHIELD NON-STERILE BLUE COLORED BUBBLE GUM SCENTED LATEX EXAMINATION...
K952591 · LYY
Shield Gloves Manufacturer Sdn. Bhd....
General Hospital · 67d
Cleared Aug 11, 1995
THEOPHYLLINE ENZYME IMMUNOASSAY
K952596 · KLS
Diagnostic Reagents, Inc.
Toxicology · 66d
Cleared Aug 11, 1995
BRANEMARK SYSTEM BALL ATTACHMENT SYSTEM
K952676 · DZE
Nobelpharma USA, Inc.
Dental · 60d
Cleared Aug 11, 1995
BOSTON MEDICAL LATEX EXAM GLOVES
K952695 · LYY
Shun Thai Rubber Gloves Industry Co.,...
General Hospital · 58d
Cleared Aug 11, 1995
BLOOD UREA NITROGEN REAGENT SYSTEM
K952742 · CDQ
Medical Diagnostic Technologies, Inc.
Chemistry · 56d
Cleared Aug 11, 1995
CREATINE KINASE REAGENT SYSTEM
K952745 · CGS
Medical Diagnostic Technologies, Inc.
Chemistry · 56d
Cleared Aug 11, 1995
SAFESKIN
K952793 · LYY
Safeskin Corp.
General Hospital · 53d
Cleared Aug 11, 1995
SAFESKIN
K952851 · LYY
Safeskin Corp.
General Hospital · 51d
Cleared Aug 11, 1995
DIA SCREEN REAGENT STRIPS
K952971 · JIL
Genesis Labs, Inc.
Chemistry · 45d
Cleared Aug 11, 1995
FORMULATION HWS-128 EPA REG. NO. 47371-130
K953009 · LRJ
Huntington Laboratories, Inc.
General Hospital · 44d
Cleared Aug 11, 1995
FORMULATION HWS-256 EPA REG. NO. 47371-129
K953010 · LRJ
Huntington Laboratories, Inc.
General Hospital · 44d
Cleared Aug 11, 1995
FORMULATION HWS-64 EPA REG. NO. 47371-131
K953011 · LRJ
Huntington Laboratories, Inc.
General Hospital · 44d
Cleared Aug 11, 1995
ANESTHESIA FACE MASK
K953295 · BSJ
Mallinckrodt Medical
Anesthesiology · 28d
Cleared Aug 11, 1995
VRS 3 WALL STAND
K953336 · IXY
Philips Medical Systems (Cleveland),...
Radiology · 25d
Cleared Aug 11, 1995
UNIVERSIX 190
K953402 · IXY
Philips Medical Systems (Cleveland),...
Radiology · 22d
Cleared Aug 11, 1995
ECLIPSE 3200
K953424 · GEX
Cardiogenes
General & Plastic Surgery · 39d
Cleared Aug 11, 1995
JEDMED SPECTRUM ENT CABINET
K953457 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 21d
Cleared Aug 11, 1995
PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION)
K953561 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 28d
Cleared Aug 10, 1995
WAVICIDE(R) -01
K914749 · MED
Wave Energy Systems, Inc.
General Hospital · 1388d