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
145249–145272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 1986
THUMPER (VIBRATOR/MASSAGER)
K860159 · IRO
Wellness Innovations Corp.
Physical Medicine · 21d
Cleared Feb 06, 1986
POWERED TRACTION EQUIPMENT
K860227 · ITH
R. P. Hood, Inc.
Physical Medicine · 15d
Cleared Feb 06, 1986
RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE
K860301 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 9d
Cleared Feb 05, 1986
HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD
K852955 · KPO
Renalchem, Inc.
Gastroenterology & Urology · 209d
Cleared Feb 05, 1986
TECHNICON H*1 SYSTEM (MPXI)
K853027 · GKZ
Technicon Instruments Corp.
Hematology · 202d
Cleared Feb 05, 1986
TECHNICON H*1 SYSTEM (HDW)
K853030 · GKL
Technicon Instruments Corp.
Hematology · 202d
Cleared Feb 05, 1986
INFANT BODY TEST
K853390 · CCM
Erich Jaeger, Inc.
Anesthesiology · 176d
Cleared Feb 05, 1986
SCREENMATE
K853409 · BZG
Erich Jaeger, Inc.
Anesthesiology · 177d
Cleared Feb 05, 1986
ERGO-PNEUMOTEST
K853434 · BZL
Erich Jaeger, Inc.
Anesthesiology · 174d
Cleared Feb 05, 1986
INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT
K853484 · GNP
Biotech Research Laboratories, Inc.
Microbiology · 169d
Cleared Feb 05, 1986
HEMOR-ICE
K854569 · LKX
Technology 2000
Gastroenterology & Urology · 83d
Cleared Feb 05, 1986
PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)
K854577 · JWY
Austin Biological Laboratories
Microbiology · 105d
Cleared Feb 05, 1986
CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
K854666 · GQI
Clinical Sciences, Inc.
Microbiology · 76d
Cleared Feb 05, 1986
SPIROMETER, MODEL TS-500 PART #SLZ7534
K855068 · BTY
Teledyne Avionics Div. of Teledyne
Anesthesiology · 49d
Cleared Feb 05, 1986
TOURIQUET KIT WITH SNARE
K855144 · GDJ
Dlp, Inc.
General & Plastic Surgery · 41d
Cleared Feb 05, 1986
MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM
K855205 · JSI
Hana Biologics, Inc.
Microbiology · 37d
Cleared Feb 05, 1986
BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)
K860056 · KCW
Berkowits School of Electrolysis, Inc.
General & Plastic Surgery · 30d
Cleared Feb 05, 1986
RX02 PLUS OXYGEN CONCENTRATOR
K860060 · CAW
The John Bunn Co.
Anesthesiology · 30d
Cleared Feb 05, 1986
ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM
K860063 · LNK
Laser Media
Gastroenterology & Urology · 30d
Cleared Feb 05, 1986
MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY
K860152 · LNK
Endo Lase, Inc.
Gastroenterology & Urology · 21d
Cleared Feb 05, 1986
CAPD TRANSFER SET SPIKE 5C4363
K860230 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 14d
Cleared Feb 05, 1986
JMS AV FISTULA NEEDLE
K860241 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 12d
Cleared Feb 05, 1986
RPMI 1640 W/GLUTAMINE W/HEPES
K860282 · KIT
Newport Biosystems, Inc.
Pathology · 8d
Cleared Feb 05, 1986
CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000
K860292 · KIR
Difco Laboratories, Inc.
Pathology · 8d