FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
136153–136176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 1988
MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA
K881290 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 27, 1988
DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH
K881332 · OCZ
Baxter Healthcare Corp
Gastroenterology & Urology · 29d
Cleared Apr 27, 1988
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
K881500 · LJP
Ortho Diagnostic Systems, Inc.
Microbiology · 16d
Cleared Apr 27, 1988
BREWER GEL FOR CAMPYLOBACTER
K881502 · KZJ
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 16d
Cleared Apr 27, 1988
A2J MZ 45 LASER LIGHT FOR POSITIONING
K881591 · IWX
A2j, Inc.
Radiology · 14d
Cleared Apr 27, 1988
ACROMED WASHERS
K881699 · HTN
Buckman Co., Inc.
Orthopedic · 8d
Cleared Apr 26, 1988
PRECISION SPINAL ADJUSTER MODEL 115
K870910 · LXM
Kinetic Technology, Inc.
Physical Medicine · 418d
Cleared Apr 26, 1988
LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH.
K880305 · LJT
Strato Medical Corp.
General Hospital · 92d
Cleared Apr 26, 1988
LYME DISEASE ELISA
K880476 · LSR
Hillcrest Biologicals
Microbiology · 82d
Cleared Apr 25, 1988
FRESENIUS PURISTERIL 340 (TM)
K874573 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 172d
Cleared Apr 25, 1988
TC2-64B TRANSCRANIAL DOPPLER
K874684 · IYO
Carolina Medical Electronics
Radiology · 165d
Cleared Apr 25, 1988
TRANS-SCAN 3-D TRANSCRANIAL DOPPLER
K874685 · IYO
Carolina Medical Electronics
Radiology · 165d
Cleared Apr 25, 1988
VIDEO ANALYZER 4000
K874750 · IBJ
Scientific Imaging, Inc.
Pathology · 159d
Cleared Apr 25, 1988
CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP
K880204 · FRN
Pharmacia Deltec, Inc.
General Hospital · 97d
Cleared Apr 25, 1988
SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
K880217 · DXK
Ge Medical Systems Information...
Cardiovascular · 96d
Cleared Apr 25, 1988
IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP
K880479 · FRN
Imed Corp.
General Hospital · 80d
Cleared Apr 25, 1988
LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE
K880592 · LLO
Laser Peripherals, LLC
Anesthesiology · 74d
Cleared Apr 25, 1988
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
K880734 · HHI
Personal Products Co.
Obstetrics & Gynecology · 61d
Cleared Apr 25, 1988
UNSCENTED MENSTRUAL PADS
K880735 · HHD
Personal Products Co.
Obstetrics & Gynecology · 61d
Cleared Apr 25, 1988
RELIANCE METAL PRIMER
K880766 · DYH
Reliance Orthodontic Products, Inc.
Dental · 59d
Cleared Apr 25, 1988
CULTURE COLLECTION DEVICE
K881105 · JSM
Medical Packaging Corp.
Microbiology · 41d
Cleared Apr 25, 1988
PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT
K881141 · CAI
Baxter Healthcare Corp
Anesthesiology · 39d
Cleared Apr 25, 1988
PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS
K881277 · LSL
Gen-Probe, Inc.
Microbiology · 38d
Cleared Apr 25, 1988
RONDEX RESCUE MASK
K881393 · BSJ
Rondex Products, Inc.
Anesthesiology · 21d