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
111313–111336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 1993
DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE
K923211 · IYO
Zeiss Humphrey System
Radiology · 495d
Cleared Nov 08, 1993
HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE
K925607 · MEH
Zimmer, Inc.
Orthopedic · 368d
Cleared Nov 08, 1993
DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH
K925653 · MDM
Dermatopathology Laboratory
General & Plastic Surgery · 364d
Cleared Nov 08, 1993
580CD DISPLAY DRIVER
K926162 · DXJ
Vidco, Inc.
Cardiovascular · 335d
Cleared Nov 08, 1993
CPR PLUS
K926333 · LIX
Kells Medical, Inc.
Cardiovascular · 327d
Cleared Nov 08, 1993
PHILIPS GYROSCAN ACS-II RELEASE 3
K930709 · LNH
Philips Medical Systems, Inc.
Radiology · 270d
Cleared Nov 08, 1993
ARC-600
K933100 · JAA
B C Medical , Ltd.
Radiology · 137d
Cleared Nov 08, 1993
IMC SALINE WET DRESSING
K933774 · FRO
Inman Medical Corp.
General & Plastic Surgery · 97d
Cleared Nov 08, 1993
PC-MINI
K934367 · JYD
GE Medical Systems
Radiology · 62d
Cleared Nov 08, 1993
PILOT CARDIOVASCULAR SYSTEMS 2 CM PILOT WIRE
K934474 · DQX
Pilot Cardiovascular Systems, Inc.,...
Cardiovascular · 55d
Cleared Nov 05, 1993
INTERGRAL III DENTAL IMPLANT SYSTEM
K923562 · DZE
Calcitek, Inc.
Dental · 476d
Cleared Nov 05, 1993
TROCAR W/ BLUNT TIP OBTURATOR
K923636 · HET
Applied Medical Resources
Obstetrics & Gynecology · 472d
Cleared Nov 05, 1993
SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE
K925351 · KWQ
Synthes (Usa)
Orthopedic · 379d
Cleared Nov 05, 1993
BIOPSY FORCEPS
K925392 · FCL
Endo-Therapeutics, Inc.
Gastroenterology & Urology · 375d
Cleared Nov 05, 1993
AMYLASE REAGENT SET (KINETIC)
K931080 · JFJ
Teco Diagnostics
Chemistry · 248d
Cleared Nov 05, 1993
GLYCOHEMOGLOBIN
K931183 · LCP
Teco Diagnostics
Hematology · 241d
Cleared Nov 05, 1993
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
K931443 · LSE
Ortho Diagnostic Systems, Inc.
Microbiology · 228d
Cleared Nov 05, 1993
CARAPACE INCISION AND DRAINAGE TRAYS
K931597 · MCZ
Carapace, Inc.
General & Plastic Surgery · 218d
Cleared Nov 05, 1993
KINGS BAY PRELUDE ONE STEP HCG COMBO KIT
K931698 · JHI
King'S Bay Intl., Inc.
Chemistry · 213d
Cleared Nov 05, 1993
NEW STACHROM PROTEIN C TEST KIT
K931906 · GGP
American Bioproducts Co.
Hematology · 206d
Cleared Nov 05, 1993
INTEGRAL III DENTAL IMPLANT ABUTMENT
K932274 · DZE
Calcitek, Inc.
Dental · 177d
Cleared Nov 05, 1993
ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM
K932467 · JJQ
Instrumentation Laboratory CO
Chemistry · 165d
Cleared Nov 05, 1993
SILICONE MIRROR
K932511 · EKJ
Moyco Industries, Inc.
Dental · 164d
Cleared Nov 05, 1993
SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY
K932724 · DXJ
Spacelabs Medical, Inc.
Cardiovascular · 151d