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
132337–132360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 1989
IRON REAGENTS ITEM NUMBER: SR1017
K890304 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Feb 10, 1989
DETECTABUSE DRUG CONTROLS
K890406 · DIF
Eastern Laboratories, Ltd.
Toxicology · 17d
Cleared Feb 10, 1989
EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR
K890451 · DLJ
Syva Co.
Toxicology · 11d
Cleared Feb 10, 1989
EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR
K890452 · DLJ
Syva Co.
Toxicology · 11d
Cleared Feb 10, 1989
ABC, ABC-1X, ABC(TM)
K890482 · KIT
Cell Ent., Inc.
Pathology · 10d
Cleared Feb 10, 1989
SECOND ASSISTANT
K890501 · FWZ
3M Company
General & Plastic Surgery · 9d
Cleared Feb 10, 1989
SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE
K890503 · GKB
Gespac, Inc.
Hematology · 9d
Cleared Feb 10, 1989
SUPERCAIR
K890523 · INX
Ssi Medical Services, Inc.
Physical Medicine · 8d
Cleared Feb 09, 1989
ANESTY 10
K880744 · GZJ
Nihon Medix Co., Ltd.
Neurology · 351d
Cleared Feb 09, 1989
INTERLABIAL PAD
K881384 · HEB
Xtramedics, Inc.
Obstetrics & Gynecology · 314d
Cleared Feb 09, 1989
AXOSTIM
K883807 · BXN
Singer Medical Products, Inc.
Anesthesiology · 154d
Cleared Feb 09, 1989
POLARIX 2 AND POLARIX 2E
K884578 · JAA
Dyna-Med
Radiology · 100d
Cleared Feb 09, 1989
CANDELA STONE BASKETS
K884738 · FFL
Candela Laser Corp.
Gastroenterology & Urology · 87d
Cleared Feb 09, 1989
CERVICAL BRUSH
K884873 · HHT
Statlab Medical Products, Inc.
Obstetrics & Gynecology · 80d
Cleared Feb 09, 1989
CENTURION(TM) MIXER
K884879 · BSZ
Matrix Medica, Inc.
Anesthesiology · 80d
Cleared Feb 09, 1989
HEMO-SANITAS SYRINGE
K884921 · FMF
Hemo-Sanitas, Inc. C/O Greenberg...
General Hospital · 73d
Cleared Feb 09, 1989
MENISCUS MENDER II LOOP
K885311 · HWQ
Instrument Makar, Inc.
Orthopedic · 42d
Cleared Feb 09, 1989
3D/DENTAL
K885322 · JAK
Columbia Scientific, Inc.
Radiology · 43d
Cleared Feb 08, 1989
CONTINUUM KNEE SYSTEM (CKS)
K882322 · JWH
Buckman Co., Inc.
Orthopedic · 247d
Cleared Feb 08, 1989
DACA-100
K882933 · LLZ
Visual Cybernetics
Radiology · 210d
Cleared Feb 08, 1989
VIRGO (R) CMV-IGG ELISA
K883102 · GQI
Electro-Nucleonics, Inc.
Microbiology · 201d
Cleared Feb 08, 1989
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650
K883111 · FKP
Baxter Healthcare Corp
Gastroenterology & Urology · 198d
Cleared Feb 08, 1989
SURGITEK (R) UROFLOW SYSTEM
K883274 · FFG
Medical Engineering Corp.
Gastroenterology & Urology · 189d
Cleared Feb 08, 1989
THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)
K883412 · DWF
Promedica Products, Inc.
Cardiovascular · 177d