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
137209–137232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1987
LIQUI-SERA SPINAL FLUID CONTROL
K874459 · JJY
Biodiagnostic Intl
Chemistry · 61d
Cleared Dec 29, 1987
MICRO-AIRE PULSE LAVAGE
K874504 · FQH
Micro-Aire Surgical Instruments, Inc.
General Hospital · 57d
Cleared Dec 29, 1987
DESERET SPLITTABLE CATHETER
K874582 · FOZ
Deseret Medical, Inc.
General Hospital · 50d
Cleared Dec 29, 1987
BENT NECK CURLCATH PERITONEAL DIALYSIS KIT
K874632 · FKX
Quinton, Inc.
Gastroenterology & Urology · 50d
Cleared Dec 29, 1987
GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS
K874878 · LSK
Gen-Probe, Inc.
Microbiology · 29d
Cleared Dec 23, 1987
H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK.
K873908 · HIT
Richmond Products, Inc.
Ophthalmic · 89d
Cleared Dec 23, 1987
GUIDE WIRE BOWL
K873942 · DQX
Condor Medical
Cardiovascular · 86d
Cleared Dec 23, 1987
2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN
K874025 · EBI
Astron Dental Corp.
Dental · 82d
Cleared Dec 23, 1987
DEVILBISS MODEL 8500D
K874041 · CAF
The Devilbiss Co.
Anesthesiology · 79d
Cleared Dec 23, 1987
OPHTHALMIC TIP & BLADE SCALPELS
K874057 · HNN
Myocure, Inc.
Ophthalmic · 79d
Cleared Dec 23, 1987
PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT
K874082 · CAF
800-Air-Wats, Inc.
Anesthesiology · 77d
Cleared Dec 23, 1987
BREATHE WITH EEZ (NASAL DILATOR)
K874089 · LWF
Breathe With Eez Corp.
Ear, Nose, Throat · 77d
Cleared Dec 23, 1987
OCS 100 (OCULAR COMPARATOR SYSTEM)
K874220 · HJO
Ocular Instruments, Inc.
Ophthalmic · 68d
Cleared Dec 23, 1987
OPMI MD SURGICAL MICROSCOPE
K874241 · FSO
Carl Zeiss, Inc.
General & Plastic Surgery · 69d
Cleared Dec 23, 1987
WIRE DRESSING
K874310 · LDF
Slocum and Neal, Inc.
Cardiovascular · 64d
Cleared Dec 23, 1987
BTE HEARING AID OTICON MODEL E39PL
K874381 · ESD
Oticon Corp.
Ear, Nose, Throat · 58d
Cleared Dec 23, 1987
RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS
K874630 · HAO
Downs Surgical , Ltd.
Neurology · 43d
Cleared Dec 23, 1987
MALIS SURGICAL LOUPES
K874845 · HJH
Valley Forge Scientific Corp.
Ophthalmic · 29d
Cleared Dec 23, 1987
DAMON D.E.T.E.C.T IMAGE ENHANCER
K874865 · LLZ
Damon Corp.
Radiology · 26d
Cleared Dec 23, 1987
WOODLYN CLASSIC REFRACTOR, PHOROPTOR
K874900 · HKN
Woodlyn, Inc.
Ophthalmic · 22d
Cleared Dec 23, 1987
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K874963 · HNA
Solway, Inc.
Ophthalmic · 21d
Cleared Dec 22, 1987
FRUCTOSAMINE TEST (ROCHE)
K854010 · LCP
Roche Diagnostic Systems, Inc.
Chemistry · 813d
Cleared Dec 22, 1987
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
K871835 · CGA
Miles Laboratories, Inc.
Chemistry · 225d
Cleared Dec 22, 1987
TELESONIC BODY STIMULATOR
K872606 · IPF
Telesonic, Inc.
Physical Medicine · 173d