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
99217–99240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 1996
MTC 7707 HIGH SPEED AIR TURBINE
K945256 · EFB
Mtc Industries and Research, Ltd.
Dental · 458d
Cleared Jan 29, 1996
CO BREATH ANALYSIS MODULE & MONOXOL II
K952694 · CCJ
Bacharach, Inc.
Anesthesiology · 229d
Cleared Jan 29, 1996
SUN MODEL OA 3000 OXYGEN ANALYZER
K952941 · CAW
Sun Medical Equipment, Inc.
Anesthesiology · 217d
Cleared Jan 29, 1996
MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)
K952984 · DQO
Map Medical Equipment, Inc.
Cardiovascular · 215d
Cleared Jan 29, 1996
AMPRI
K954002 · KGO
Ampri Rubberware Industries Sdn Bhd
General Hospital · 157d
Cleared Jan 29, 1996
PEN-INJECT 2.25
K954729 · KZH
Scandinavian Health , Ltd.
General Hospital · 108d
Cleared Jan 29, 1996
HANEL MAVIG MONITOR SUSPENSION SYSTEM
K954945 · JAA
F. Walter Hanel GmbH
Radiology · 91d
Cleared Jan 29, 1996
LILY DARK VIEWER
K954998 · IXC
Lily Imaging Solutions Co.
Radiology · 89d
Cleared Jan 29, 1996
ZONG RONG SUNGLASSES
K955287 · HQY
Yuu Yeng Enterprise Co., Ltd.
Ophthalmic · 73d
Cleared Jan 29, 1996
DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE
K955335 · IKT
Chalgren Enterprises, Inc.
Neurology · 70d
Cleared Jan 29, 1996
ACCESS FOLATE ASSAY (MODIFICATION)
K955434 · CGN
Beckman Coulter, Inc.
Chemistry · 119d
Cleared Jan 29, 1996
URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)
K955438 · JIR
Teco Diagnostics
Chemistry · 82d
Cleared Jan 29, 1996
ZONG RONG SUNGLASSES
K955441 · HQY
Zong Rong Glasses Ltd. Co.
Ophthalmic · 69d
Cleared Jan 29, 1996
PLASTIC FRAME, METAL FRAME, OPTICAL
K955695 · HQY
Dah Sing Trading Co.
Ophthalmic · 47d
Cleared Jan 26, 1996
PHENYLALANINE TEST KIT
K943547 · JNB
Isolab, Inc.
Chemistry · 554d
Cleared Jan 26, 1996
ABSORBABLE BONE SCREW
K944544 · MAI
Johnson & Johnson Professionals, Inc.
Orthopedic · 498d
Cleared Jan 26, 1996
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED,...
K945212 · GKZ
Dako Corp.
Hematology · 458d
Cleared Jan 26, 1996
MIELE G 7781 DENTAL THERMAL DISINFECTOR
K950518 · LDS
Miele Professional
General Hospital · 354d
Cleared Jan 26, 1996
NEURONET
K952294 · GWF
Computational Diagnostics, Inc.
Neurology · 255d
Cleared Jan 26, 1996
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
K952819 · GTZ
Abbott Laboratories
Microbiology · 220d
Cleared Jan 26, 1996
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250 · IZH
GE Medical Systems
Radiology · 198d
Cleared Jan 26, 1996
E-Z FLEX
K953456 · BXB
Fluid Motion Biotechnologies, Inc.
Physical Medicine · 191d
Cleared Jan 26, 1996
STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM
K953529 · LJT
Strato/Infusaid, Inc.
General Hospital · 183d
Cleared Jan 26, 1996
LUBRICATED CONDOM
K953583 · HIS
Tactyl Technologies, Inc.
Obstetrics & Gynecology · 178d