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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
135337–135360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1988
HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.
K881136 · DQA
Hewlett-Packard Co.
Anesthesiology · 63d
Cleared May 18, 1988
IMPULSE TVC (RICHARDS, OMNI, MARCON)
K881143 · ESD
Richards Medical Co., Inc.
Ear, Nose, Throat · 62d
Cleared May 18, 1988
ACCUTONE IN-THE-EAR HEARING AID
K881193 · ESD
Interstate Hearing Aid Service
Ear, Nose, Throat · 58d
Cleared May 18, 1988
EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
K881279 · DTI
Baxter Healthcare Corp
Cardiovascular · 57d
Cleared May 18, 1988
COAG-A-MATE(R) XM
K881281 · GKP
Organon Teknika Corp.
Hematology · 54d
Cleared May 18, 1988
MODEL 375 ECG
K881328 · DPS
Birtcher Corp.
Cardiovascular · 50d
Cleared May 18, 1988
MODIFIED IDS RAPID NH SYSTEM
K881501 · JSX
Innovative Diagnostic Systems, Inc.
Microbiology · 37d
Cleared May 18, 1988
DTV-4114 FLUOROSCOPIC TELEVISION CAMERA
K881688 · IZJ
Adac Laboratories
Radiology · 29d
Cleared May 18, 1988
GORE-TEX VASCULAR GRAFT
K881732 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 26d
Cleared May 18, 1988
INTRODUCTION/DRAINAGE CATHETER & ACCESS
K881873 · GBS
Sheridan Catheter Corp.
General & Plastic Surgery · 15d
Cleared May 18, 1988
LABELING CHANGE TO SURGICAL FACE MASK
K881910 · FXX
Louis M. Gerson Co., Inc.
General Hospital · 19d
Cleared May 17, 1988
PREGNANCY (HCG) CARD & LIQUID TEST
K880163 · JHJ
Ampcor, Inc.
Chemistry · 125d
Cleared May 17, 1988
MAGNESIUM LIQUID STABLE REAGENT SET
K881300 · JGJ
Medical Analysis Systems, Inc.
Chemistry · 50d
Cleared May 17, 1988
BREATH-EASY
K881308 · BYD
Icor AB
Anesthesiology · 50d
Cleared May 17, 1988
SIMPLICITY SERIES 5
K881634 · IQA
Quartet Technology, Inc.
Physical Medicine · 33d
Cleared May 17, 1988
BATTERY PACKS FOR CARDIOVASCULAR UNITS
K881643 · MHX
Dowit Service Co., Inc.
Cardiovascular · 43d
Cleared May 17, 1988
REM 250 THREE WHEELED ELECTRIC CART
K881766 · INI
Royal Enterprises Manufacturing, Inc.
Physical Medicine · 22d
Cleared May 16, 1988
PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101
K875118 · JOM
Bloodflow Laboratory, Inc.
Cardiovascular · 153d
Cleared May 16, 1988
BRUSHRITE
K880442 · JEG
Pro Care Laboratories, Inc.
Anesthesiology · 104d
Cleared May 16, 1988
ADVANCE* AND DAISY* PREGNANCY TEST
K880472 · LCX
Advanced Care Products
Chemistry · 102d
Cleared May 16, 1988
FUJI CAP II CAPSULE & APPLIER
K880848 · EMA
G-C Intl. Corp.
Dental · 76d
Cleared May 16, 1988
PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA
K880899 · DHB
Pharmacia, Inc.
Immunology · 75d
Cleared May 16, 1988
VASCU-CARE ANGIOSCOPE
K880927 · DQX
Vascu-Care, Inc.
Cardiovascular · 73d
Cleared May 16, 1988
SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER
K881197 · LIT
Schneider-Shilley (Usa)
Cardiovascular · 56d