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
157057–157080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1983
FREEDOM
K823849 · IOR
Carbonite Corp.
Physical Medicine · 112d
Cleared Apr 12, 1983
DEFIGARD M(OR DEFISCOPE M
K823931 · LDD
Odam
Cardiovascular · 104d
Cleared Apr 12, 1983
MINIDEF (OR DEFIPORT
K823933 · LDD
Odam
Cardiovascular · 104d
Cleared Apr 12, 1983
ULTRASONIC MEDICAL DEVICE MODEL 3 LO 4
K827708
Sterisson
Radiology · 274d
Cleared Apr 12, 1983
INFLATABLE PENILE PROSTH. - CYLINDER
K830048 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 92d
Cleared Apr 12, 1983
BEAR JET 150 VENTILATOR
K830165 · FLI
Bear Medical Systems, Inc.
General Hospital · 84d
Cleared Apr 12, 1983
SPHYGMOLOG II MODEL D
K830184 · DXN
Cardiodyne General, Inc.
Cardiovascular · 89d
Cleared Apr 12, 1983
AUTO SUTURE TA DISPOS-STAPLE CART
K830199 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 82d
Cleared Apr 12, 1983
VARIOUS INSTRUMENTS & INSTRUMENT TRAYS
K830219 · FSM
Ascep, Inc.
General & Plastic Surgery · 78d
Cleared Apr 12, 1983
IMSI/METRIPOND HAND OPERATING TABLE
K830339 · FSE
Intl. Management Services, Inc.
General & Plastic Surgery · 70d
Cleared Apr 12, 1983
PEM-C
K830397 · JSF
Health Development Corp.
Microbiology · 64d
Cleared Apr 12, 1983
DISPOSABLE INTRA-ARTICULAR BLADE
K830434 · GFA
Concept, Inc.
General & Plastic Surgery · 62d
Cleared Apr 12, 1983
MODEL 200
K830468 · FTZ
Western Laboratories Corp.
Ophthalmic · 56d
Cleared Apr 12, 1983
SURGITEK ULTRA-LO CUFF
K830504 · BTR
Mec/Surgitek Products
Anesthesiology · 55d
Cleared Apr 12, 1983
CHALLENGER #450
K830519 · DSH
Transmed, Inc.
Cardiovascular · 54d
Cleared Apr 12, 1983
N.E.W. NEB
K830527
San Diego Plastics, Inc.
Gastroenterology & Urology
Cleared Apr 12, 1983
ELECTROSURGICAL GROUND PAD-DISPERSIVE
K830613 · GEI
Con Med Equipment, Inc.
General & Plastic Surgery · 43d
Cleared Apr 12, 1983
BLOOD LINE SETS FOR HEMOFILTRATION
K830677 · FJK
Gambro, Inc.
Gastroenterology & Urology · 39d
Cleared Apr 12, 1983
ONE TIME DISPOSABLE SKIN STAPLER
K830704 · FZQ
Acme United Corp.
General & Plastic Surgery · 36d
Cleared Apr 12, 1983
WIRE TWISTERS
K830721 · HTC
The Anspach Effort, Inc.
General & Plastic Surgery · 35d
Cleared Apr 12, 1983
REDI-DRAPE
K830723 · KKX
The Oec Group
General Hospital · 35d
Cleared Apr 12, 1983
FORGARTY BALLOON CALIBRATOR
K830734 · DQO
American Edwards Laboratories
Cardiovascular · 35d
Cleared Apr 12, 1983
ADT DISPOSABLE SCALPEL W/STAINLESS STEEL
K830745 · GDX
Lab Industries, Inc.
General & Plastic Surgery · 35d
Cleared Apr 12, 1983
OLYMPUS HIGH SPEED ANALYZER
K830762 · JJE
Olympus Corp.
Chemistry · 33d